Trial Outcomes & Findings for Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives (NCT NCT02757872)
NCT ID: NCT02757872
Last Updated: 2024-05-31
Results Overview
Serum creatinine and cystatin C measurement pre-randomization and year 4
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2232 participants
Primary outcome timeframe
Baseline and 4 years
Results posted on
2024-05-31
Participant Flow
Participant milestones
| Measure |
Vitamin D and Omega-3 Fatty Acids
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
Vitamin D and Omega-3 Fatty Acid Placebo
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo)
|
Vitamin D Placebo and Omega-3 Fatty Acids
Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo
|
Vitamin D Placebo and Omega-3 Fatty Acids Placebo
Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo
Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
545
|
570
|
576
|
541
|
|
Overall Study
COMPLETED
|
545
|
570
|
576
|
541
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives
Baseline characteristics by cohort
| Measure |
Vitamin D and Omega-3 Fatty Acids
n=545 Participants
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
Vitamin D and Omega-3 Fatty Acid Placebo
n=570 Participants
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo)
|
Vitamin D Placebo and Omega-3 Fatty Acids
n=576 Participants
Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo
|
Vitamin D Placebo and Omega-3 Fatty Acids Placebo
n=541 Participants
Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo
Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day
|
Total
n=2232 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 6.0 • n=99 Participants
|
69.0 years
STANDARD_DEVIATION 6.4 • n=107 Participants
|
69.0 years
STANDARD_DEVIATION 6.2 • n=206 Participants
|
68.3 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 6.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
278 Participants
n=99 Participants
|
309 Participants
n=107 Participants
|
303 Participants
n=206 Participants
|
285 Participants
n=7 Participants
|
1175 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
267 Participants
n=99 Participants
|
261 Participants
n=107 Participants
|
273 Participants
n=206 Participants
|
256 Participants
n=7 Participants
|
1057 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
438 Participants
n=99 Participants
|
437 Participants
n=107 Participants
|
442 Participants
n=206 Participants
|
419 Participants
n=7 Participants
|
1736 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
58 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
73 Participants
n=7 Participants
|
289 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
67 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
44 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
55 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
545 participants
n=99 Participants
|
570 participants
n=107 Participants
|
576 participants
n=206 Participants
|
541 participants
n=7 Participants
|
2232 participants
n=31 Participants
|
|
Creatinine
|
0.89 mg/dL
STANDARD_DEVIATION 0.23 • n=99 Participants
|
0.89 mg/dL
STANDARD_DEVIATION 0.24 • n=107 Participants
|
0.90 mg/dL
STANDARD_DEVIATION 0.35 • n=206 Participants
|
0.87 mg/dL
STANDARD_DEVIATION 0.22 • n=7 Participants
|
0.89 mg/dL
STANDARD_DEVIATION 0.26 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 yearsPopulation: Glomerular filtration rate data was not collected as samples were never analyzed.
Serum creatinine and cystatin C measurement pre-randomization and year 4
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 years post-randomizationPopulation: Urine samples were not collected from 34 participants in the 'Vitamin D and Fish Oil' group; 41 participants in the 'Vitamin D and Fish Oil Placebo' group; 33 participants in the 'Vitamin D Placebo and Fish Oil' group; and 35 participants in the 'Vitamin D Placebo and Fish Oil Placebo' group. As such, there was no data to analyze from these participants.
Number of participants with positive Microalbuminuria was reported. Participants were defined as having positive microalbuminuria if their lab results were \>30 mg/g Creatinine
Outcome measures
| Measure |
Vitamin D and Omega-3 Fatty Acids
n=511 Participants
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
Vitamin D and Omega-3 Fatty Acid Placebo
n=529 Participants
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo)
|
Vitamin D Placebo and Omega-3 Fatty Acids
n=543 Participants
Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo
|
Vitamin D Placebo and Omega-3 Fatty Acids Placebo
n=506 Participants
Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo
Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day
|
|---|---|---|---|---|
|
Confirmation of Microalbuminuria
|
4 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
Adverse Events
Vitamin D and Omega-3 Fatty Acids
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vitamin D and Omega-3 Fatty Acid Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Vitamin D Placebo and Omega-3 Fatty Acids
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Vitamin D Placebo and Omega-3 Fatty Acids Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitamin D and Omega-3 Fatty Acids
n=545 participants at risk
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
Vitamin D and Omega-3 Fatty Acid Placebo
n=570 participants at risk
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo)
|
Vitamin D Placebo and Omega-3 Fatty Acids
n=576 participants at risk
Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo
|
Vitamin D Placebo and Omega-3 Fatty Acids Placebo
n=541 participants at risk
Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo
Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day
|
|---|---|---|---|---|
|
Renal and urinary disorders
Microalbuminuria
|
0.73%
4/545 • 4 years
This ancillary study is not administering any treatments. All treatment monitoring occurred through the parent VITAL study (NCT01169259). The only adverse events obtained were in conjunction with results from laboratory samples collected for analysis at \~4 years
|
1.1%
6/570 • 4 years
This ancillary study is not administering any treatments. All treatment monitoring occurred through the parent VITAL study (NCT01169259). The only adverse events obtained were in conjunction with results from laboratory samples collected for analysis at \~4 years
|
1.0%
6/576 • 4 years
This ancillary study is not administering any treatments. All treatment monitoring occurred through the parent VITAL study (NCT01169259). The only adverse events obtained were in conjunction with results from laboratory samples collected for analysis at \~4 years
|
1.1%
6/541 • 4 years
This ancillary study is not administering any treatments. All treatment monitoring occurred through the parent VITAL study (NCT01169259). The only adverse events obtained were in conjunction with results from laboratory samples collected for analysis at \~4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place