Trial Outcomes & Findings for Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes (NCT NCT01633177)
NCT ID: NCT01633177
Last Updated: 2026-04-03
Results Overview
Incident type 2 diabetes during follow-up
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
22220 participants
Primary outcome timeframe
5 years
Results posted on
2026-04-03
Participant Flow
2011 -2014
Participant milestones
| Measure |
Vitamin D and Omega-3
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
Vitamin D and Omega-3 Placebo
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Omega-3 Placebo
|
Vitamin D Placebo and Omega-3
Vitamin D Placebo and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
Vitamin D Placebo and Omega-3 Placebo
Vitamin D3 Placebo and Omega-3 Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5519
|
5543
|
5572
|
5586
|
|
Overall Study
COMPLETED
|
5519
|
5543
|
5572
|
5586
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes
Baseline characteristics by cohort
| Measure |
Vitamin D and Omega-3
n=5519 Participants
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\], per day
|
Vitamin D and Omega-3 Placebo
n=5543 Participants
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Omega-3 Placebo
|
Vitamin D Placebo and Omega-3
n=5572 Participants
Vitamin D Placebo and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\], per day
|
Vitamin D Placebo and Omega-3 Placebo
n=5586 Participants
Vitamin D Placebo and Omega-3 Placebo
|
Total
n=22220 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2087 Participants
n=5 Participants
|
2086 Participants
n=5 Participants
|
2103 Participants
n=10 Participants
|
2111 Participants
n=5 Participants
|
8387 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
3432 Participants
n=5 Participants
|
3457 Participants
n=5 Participants
|
3469 Participants
n=10 Participants
|
3475 Participants
n=5 Participants
|
13833 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
2781 Participants
n=5 Participants
|
2819 Participants
n=5 Participants
|
2805 Participants
n=10 Participants
|
2810 Participants
n=5 Participants
|
11215 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
2738 Participants
n=5 Participants
|
2724 Participants
n=5 Participants
|
2767 Participants
n=10 Participants
|
2776 Participants
n=5 Participants
|
11005 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
4025 Participants
n=5 Participants
|
4023 Participants
n=5 Participants
|
4042 Participants
n=10 Participants
|
4031 Participants
n=5 Participants
|
16121 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
African American
|
958 Participants
n=5 Participants
|
947 Participants
n=5 Participants
|
958 Participants
n=10 Participants
|
989 Participants
n=5 Participants
|
3852 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Hispanic (Non-African American)
|
189 Participants
n=5 Participants
|
217 Participants
n=5 Participants
|
195 Participants
n=10 Participants
|
202 Participants
n=5 Participants
|
803 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Asian / Pacific Islander
|
76 Participants
n=5 Participants
|
70 Participants
n=5 Participants
|
78 Participants
n=10 Participants
|
82 Participants
n=5 Participants
|
306 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaska Native
|
51 Participants
n=5 Participants
|
43 Participants
n=5 Participants
|
55 Participants
n=10 Participants
|
43 Participants
n=5 Participants
|
192 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Other / Unknown
|
105 Participants
n=5 Participants
|
111 Participants
n=5 Participants
|
112 Participants
n=10 Participants
|
118 Participants
n=5 Participants
|
446 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Missing Response to Race/Ethnicity
|
115 Participants
n=5 Participants
|
132 Participants
n=5 Participants
|
132 Participants
n=10 Participants
|
121 Participants
n=5 Participants
|
500 Participants
n=11 Participants
|
|
Hypertension treated with medication
|
2500 Participants
n=5 Participants
|
2647 Participants
n=5 Participants
|
2659 Participants
n=10 Participants
|
2634 Participants
n=5 Participants
|
10440 Participants
n=11 Participants
|
|
Cholesterol-lowering medication use
|
1818 Participants
n=5 Participants
|
1818 Participants
n=5 Participants
|
1840 Participants
n=10 Participants
|
1793 Participants
n=5 Participants
|
7269 Participants
n=11 Participants
|
|
Vitamin D supplement use ≤800 ID/d
|
2395 Participants
n=5 Participants
|
2450 Participants
n=5 Participants
|
2444 Participants
n=10 Participants
|
2436 Participants
n=5 Participants
|
9725 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: 5 yearsIncident type 2 diabetes during follow-up
Outcome measures
| Measure |
Vitamin D and Omega-3 Placebo
n=5543 Participants
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Omega-3 Placebo
|
Vitamin D Placebo and Omega-3
n=5572 Participants
Vitamin D Placebo and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
Vitamin D Placebo and Omega-3 Placebo
n=5586 Participants
Vitamin D Placebo and Omega-3 Placebo
|
Vitamin D and Omega-3
n=5519 Participants
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
|---|---|---|---|---|
|
Incident Type 2 Diabetes
|
109 Participants
|
139 Participants
|
115 Participants
|
121 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: There were 911 VITAL-CTSC participants without T2D at baseline and eligible for analyses. Of these, 847 also provided blood samples at the follow-up visit at 2 years. Of these, 786 had complete data on baseline and 2 year Mastuda ISI.
Matsuda Insulin Sensitivity Index (ISI). Change from baseline is calculated as follow-up minus baseline. Negative values represent a decrease in the outcome measure and therefore indicate worsening. For example, a change of -3.5 reflects a greater decline than a change of -3.0.
Outcome measures
| Measure |
Vitamin D and Omega-3 Placebo
n=188 Participants
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Omega-3 Placebo
|
Vitamin D Placebo and Omega-3
n=201 Participants
Vitamin D Placebo and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
Vitamin D Placebo and Omega-3 Placebo
n=206 Participants
Vitamin D Placebo and Omega-3 Placebo
|
Vitamin D and Omega-3
n=191 Participants
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
|---|---|---|---|---|
|
OGTT Index of Insulin Sensitivity
|
-3.5 percentage of baseline
Interval -8.5 to 1.7
|
-5.2 percentage of baseline
Interval -9.9 to -0.2
|
-3.0 percentage of baseline
Interval -7.8 to 2.0
|
-3.3 percentage of baseline
Interval -8.2 to 1.9
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: There were 911 VITAL-CTSC participants without T2D at baseline and eligible for analyses. Of these, 847 also provided blood samples at the follow-up visit at 2 years. Of these, 822 had complete data on baseline and 2 year HOMA-β beta cell function index.
HOMA-β beta cell function index. Negative values indicate a decrease in estimated β-cell function from baseline; larger absolute values reflect greater magnitude of change.
Outcome measures
| Measure |
Vitamin D and Omega-3 Placebo
n=198 Participants
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Omega-3 Placebo
|
Vitamin D Placebo and Omega-3
n=211 Participants
Vitamin D Placebo and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
Vitamin D Placebo and Omega-3 Placebo
n=213 Participants
Vitamin D Placebo and Omega-3 Placebo
|
Vitamin D and Omega-3
n=200 Participants
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
|---|---|---|---|---|
|
OGTT Index of Beta-cell Function
|
-2.3 percentage of baseline
Interval -2.8 to 7.7
|
2.7 percentage of baseline
Interval -2.3 to 7.9
|
-1.7 percentage of baseline
Interval -6.5 to 3.3
|
-0.8 percentage of baseline
Interval -5.7 to 4.4
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: There were 911 VITAL-CTSC participants without T2D at baseline and eligible for analyses. Of these, 847 also provided blood samples at the follow-up visit at 2 years. Of these, all 847 had complete data on baseline and 2 year HbA1c.
Hemoglobin A1c
Outcome measures
| Measure |
Vitamin D and Omega-3 Placebo
n=204 Participants
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Omega-3 Placebo
|
Vitamin D Placebo and Omega-3
n=217 Participants
Vitamin D Placebo and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
Vitamin D Placebo and Omega-3 Placebo
n=219 Participants
Vitamin D Placebo and Omega-3 Placebo
|
Vitamin D and Omega-3
n=207 Participants
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
|---|---|---|---|---|
|
HbA1c Levels
|
0.5 % change
Interval 0.0 to 1.0
|
0.2 % change
Interval -0.3 to 0.7
|
0.5 % change
Interval -0.1 to 1.0
|
0.2 % change
Interval -0.4 to 0.7
|
Adverse Events
Vitamin D and Omega-3
Serious events: 661 serious events
Other events: 4317 other events
Deaths: 189 deaths
Vitamin D and Omega-3 Placebo
Serious events: 639 serious events
Other events: 4282 other events
Deaths: 185 deaths
Vitamin D Placebo and Omega-3
Serious events: 670 serious events
Other events: 4302 other events
Deaths: 201 deaths
Vitamin D Placebo and Omega-3 Placebo
Serious events: 704 serious events
Other events: 4372 other events
Deaths: 192 deaths
Serious adverse events
| Measure |
Vitamin D and Omega-3
n=5519 participants at risk
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
Vitamin D and Omega-3 Placebo
n=5543 participants at risk
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Omega-3 Placebo
|
Vitamin D Placebo and Omega-3
n=5572 participants at risk
Vitamin D Placebo and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
Vitamin D Placebo and Omega-3 Placebo
n=5586 participants at risk
Vitamin D Placebo and Omega-3 Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
2.4%
134/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
2.4%
134/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
2.9%
161/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
3.1%
172/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Endocrine disorders
Hypercalcemia
|
1.1%
58/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.94%
52/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.97%
54/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.98%
55/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Nervous system disorders
Stroke
|
0.96%
53/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.1%
61/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.1%
61/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.97%
54/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Cancer of Any Type
|
6.5%
356/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
6.0%
332/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
6.3%
351/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
6.5%
364/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death from Cancer
|
1.1%
63/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.2%
64/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.5%
82/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.5%
83/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.92%
51/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.1%
60/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.92%
51/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.98%
55/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.7%
96/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.3%
72/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.6%
91/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.8%
98/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
0.47%
26/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.31%
17/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.43%
24/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.34%
19/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Cardiac disorders
Major Cardiovascular Event
|
2.8%
156/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
3.0%
166/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
2.8%
157/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
2.9%
161/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Cardiac disorders
Myocardial Infarction
|
1.1%
60/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.3%
74/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.1%
60/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.4%
80/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Cardiac disorders
Death from Cardiovascular Cause
|
1.2%
65/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
1.1%
60/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.93%
52/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.91%
51/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
Other adverse events
| Measure |
Vitamin D and Omega-3
n=5519 participants at risk
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
Vitamin D and Omega-3 Placebo
n=5543 participants at risk
Vitamin D3 (cholecalciferol) tablet 2000 IU per day and Omega-3 Placebo
|
Vitamin D Placebo and Omega-3
n=5572 participants at risk
Vitamin D Placebo and Marine omega 3 fatty acids including eicosapentaenoic acid \[EPA, 460 mg\] + docosahexaenoic acid \[DHA, 380 mg\] per day
|
Vitamin D Placebo and Omega-3 Placebo
n=5586 participants at risk
Vitamin D Placebo and Omega-3 Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Stomach Upset or Pain
|
37.2%
2052/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
37.2%
2060/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
36.8%
2053/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
36.8%
2055/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Gastrointestinal disorders
Nausea
|
25.9%
1428/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
26.6%
1476/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
26.9%
1498/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
26.3%
1471/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Gastrointestinal disorders
Constipation
|
38.4%
2121/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
38.4%
2128/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
38.9%
2167/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
37.8%
2114/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Gastrointestinal disorders
Diarrhea
|
41.6%
2294/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
40.8%
2263/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
42.0%
2343/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
42.5%
2376/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Gastrointestinal disorders
Increased Burping
|
16.9%
933/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
15.9%
880/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
16.7%
931/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
16.6%
925/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Gastrointestinal disorders
Bad Taste in Mouth
|
16.1%
889/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
15.4%
856/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
16.3%
907/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
16.6%
925/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Renal and urinary disorders
Kidney Stones
|
3.3%
181/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
3.8%
209/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
2.9%
159/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
3.5%
193/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Renal and urinary disorders
Kidney Failure or Dialysis
|
0.49%
27/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.56%
31/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.66%
37/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.66%
37/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
25.0%
1381/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
25.0%
1383/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
26.2%
1461/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
26.7%
1490/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Skin and subcutaneous tissue disorders
Easy Bruising
|
26.7%
1474/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
26.0%
1440/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
26.1%
1455/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
25.5%
1424/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Blood and lymphatic system disorders
Frequent Nosebleeds
|
3.4%
189/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
3.7%
206/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
3.7%
208/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
3.5%
198/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Renal and urinary disorders
Blood in Urine
|
7.1%
392/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
6.7%
371/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
6.7%
375/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
6.6%
368/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
|
Endocrine disorders
Parathyroid Condition
|
0.24%
13/5519 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.41%
23/5543 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.34%
19/5572 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
0.55%
31/5586 • Median follow-up 5.3 years
This was a secondary analysis of the main study. AEs were not collected separately for this subgroup analysis. Participants reported occurrence of medical events on annual questionnaires.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place