Trial Outcomes & Findings for Vitamin D for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer (NCT NCT01744821)
NCT ID: NCT01744821
Last Updated: 2015-07-23
Results Overview
Activation of apoptosis via immunohistochemical measurement of activation of caspase activity, as well as expression of BAX and BCL-2 The primary marker outcomes will be assessed for normality and compared between groups using a two-sample t-test or a Wilcoxon rank sum test. Other markers will be compared similarly if continuous, or by Fisher's exact test if categorical.
TERMINATED
NA
7 participants
Up to 24 months
2015-07-23
Participant Flow
Eligible participants were women at high risk for ovarian cancer and undergoing a prophylactic salpingo-oophorectomy. Subjects were recruited in the outpatient gynecologic oncology clinics of the study investigators. The study opened 6/1/12 with a goal of 80 subjects. It closed on 1/12/15 with a total of 7 subjects.
Baseline evaluation included physical examination, personal and family history questionnaire, and blood test including serum 25(OH)D. Based on vitamin D level, subjects were randomized to 1 of 4 groups.
Participant milestones
| Measure |
Vitamin D 50,000 IU Weekly
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
|
Placebo 50,000 IU Weekly
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
|
Vitamin D 2,000 IU Daily
If Vitamin D level is\>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
|
Placebo 2,000 IU Daily
If Vitamin D level is\>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
2
|
1
|
|
Overall Study
COMPLETED
|
1
|
3
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Vitamin D 50,000 IU Weekly
n=1 Participants
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
|
Placebo 50,000 IU Weekly
n=3 Participants
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
|
Vitamin D 2,000 IU Daily
n=2 Participants
If Vitamin D level is\>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
|
Placebo 2,000 IU Daily
n=1 Participants
If Vitamin D level is\>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
1 participants
n=7 Participants
|
7 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.
Activation of apoptosis via immunohistochemical measurement of activation of caspase activity, as well as expression of BAX and BCL-2 The primary marker outcomes will be assessed for normality and compared between groups using a two-sample t-test or a Wilcoxon rank sum test. Other markers will be compared similarly if continuous, or by Fisher's exact test if categorical.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.
Decrease in cellular proliferation measured by immunohistochemistry staining with KI67
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.
The outcomes that will be measured for the secondary objectives of this study will include the following: Review of standard pathologic evaluation with specific attention to histologic markers including serous hyperplasia, tubal atypia, and p53 signature in the ovary and fallopian tube, and examine via immunohistochemistry the effects of vitamin D supplementation on expression of the TGF-beta isoforms and CYP24
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsDifferences in the types and incidence of toxicities associated with Vitamin D3 replacement, specifically hypercalcemia, with increasing levels of Vitamin D3 along with the effectiveness of Vitamin D3 supplementation on increasing serum levels of Vitamin D
Outcome measures
| Measure |
Vitamin D 50,000 IU Weekly
n=1 Participants
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
|
Placebo 50,000 IU Weekly
n=3 Participants
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
|
Vitamin D 2,000 IU Daily
n=2 Participants
If Vitamin D level is\>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
|
Placebo 2,000 IU Daily
n=1 Participants
If Vitamin D level is\>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
|
|---|---|---|---|---|
|
Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.
Fatige grade 1
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.
Headache grade 1
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.
Hypercalcemia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.
Loss of Appetite grade 1
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.
Dry Mouth grade 1
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.
Constipation grade 1
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.
Weakness grade 1
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Vitamin D 50,000 IU Weekly
Placebo 50,000 IU Weekly
Vitamin D 2,000 IU Daily
Placebo 2,000 IU Daily
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitamin D 50,000 IU Weekly
n=1 participants at risk
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
|
Placebo 50,000 IU Weekly
n=3 participants at risk
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
|
Vitamin D 2,000 IU Daily
n=2 participants at risk
If Vitamin D level is\>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
|
Placebo 2,000 IU Daily
n=1 participants at risk
If Vitamin D level is\>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • 8 weeks
|
0.00%
0/3 • 8 weeks
|
100.0%
2/2 • Number of events 2 • 8 weeks
|
0.00%
0/1 • 8 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • 8 weeks
|
33.3%
1/3 • Number of events 1 • 8 weeks
|
50.0%
1/2 • Number of events 1 • 8 weeks
|
0.00%
0/1 • 8 weeks
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • 8 weeks
|
0.00%
0/3 • 8 weeks
|
0.00%
0/2 • 8 weeks
|
0.00%
0/1 • 8 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
100.0%
1/1 • Number of events 1 • 8 weeks
|
33.3%
1/3 • Number of events 1 • 8 weeks
|
0.00%
0/2 • 8 weeks
|
0.00%
0/1 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
100.0%
1/1 • Number of events 1 • 8 weeks
|
0.00%
0/3 • 8 weeks
|
0.00%
0/2 • 8 weeks
|
0.00%
0/1 • 8 weeks
|
|
Metabolism and nutrition disorders
Loss of Appetite
|
0.00%
0/1 • 8 weeks
|
33.3%
1/3 • Number of events 1 • 8 weeks
|
0.00%
0/2 • 8 weeks
|
0.00%
0/1 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place