Trial Outcomes & Findings for The Effects of Vitamin D on Angiogenic Factors in Women With Polycystic Ovary Syndrome (NCT NCT02460380)
NCT ID: NCT02460380
Last Updated: 2018-10-12
Results Overview
Serum TGF-β1/sENG ratio as a measure of TGF-β1 bioavailability
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
93 participants
Primary outcome timeframe
Baseline (pre-treatment) and 8 weeks later (post-treatment)
Results posted on
2018-10-12
Participant Flow
A total of 93 women were screened for vitamin D deficiency. Sixty-eight women were diagnosed with vitamin D deficiency and were included in the study and randomly allocated into the two groups.
Participant milestones
| Measure |
Vitamin D3
Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
|
Placebo
Women in the placebo group received once capsule of placebo once weekly for eight weeks.
Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
23
|
|
Overall Study
COMPLETED
|
35
|
18
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Vitamin D3
Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
|
Placebo
Women in the placebo group received once capsule of placebo once weekly for eight weeks.
Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
5
|
Baseline Characteristics
The Effects of Vitamin D on Angiogenic Factors in Women With Polycystic Ovary Syndrome
Baseline characteristics by cohort
| Measure |
Vitamin D3
n=45 Participants
Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
|
Placebo
n=23 Participants
Women in the placebo group received once capsule of placebo once weekly for eight weeks.
Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 6.4 • n=35 Participants
|
29.6 years
STANDARD_DEVIATION 7.6 • n=18 Participants
|
30.2 years
STANDARD_DEVIATION 6.8 • n=53 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=35 Participants
|
18 Participants
n=18 Participants
|
53 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=35 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=45 Participants
|
17 Participants
n=23 Participants
|
48 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=45 Participants
|
6 Participants
n=23 Participants
|
20 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=35 Participants
|
18 Participants
n=18 Participants
|
53 Participants
n=53 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment) and 8 weeks later (post-treatment)Serum TGF-β1/sENG ratio as a measure of TGF-β1 bioavailability
Outcome measures
| Measure |
Vitamin D3
n=35 Participants
Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
|
Placebo
n=18 Participants
Women in the placebo group received once capsule of placebo once weekly for eight weeks.
Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks
|
|---|---|---|
|
Effect of Vitamin D on Angiogenic Factors
Serum TGF-β1/sENG before treatment
|
6.7 ratio
Standard Error 0.4
|
5.6 ratio
Standard Error 0.5
|
|
Effect of Vitamin D on Angiogenic Factors
Serum TGF-β1/sENG after treatment
|
5.9 ratio
Standard Error 0.4
|
5.5 ratio
Standard Error 0.4
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment) and 8 weeks later (post-treatment)Serum VEGF level
Outcome measures
| Measure |
Vitamin D3
n=35 Participants
Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
|
Placebo
n=18 Participants
Women in the placebo group received once capsule of placebo once weekly for eight weeks.
Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks
|
|---|---|---|
|
Effect of Vitamin D on Angiogenic Factors
Serum VEGF level before treatment
|
1106.4 pg/mL
Standard Error 36.5
|
893.1 pg/mL
Standard Error 90.2
|
|
Effect of Vitamin D on Angiogenic Factors
Serum VEGF level after treatment
|
965.3 pg/mL
Standard Error 42.7
|
866 pg/mL
Standard Error 70.8
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)Interval between periods as a measure ovulatory dysfunction
Outcome measures
| Measure |
Vitamin D3
n=35 Participants
Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
|
Placebo
n=18 Participants
Women in the placebo group received once capsule of placebo once weekly for eight weeks.
Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks
|
|---|---|---|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Interval between periods before treatment
|
80.2 Days
Standard Error 9.8
|
79 Days
Standard Error 9
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Interval between periods after treatment
|
60 Days
Standard Error 6.7
|
75 Days
Standard Error 9
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)Blood pressure
Outcome measures
| Measure |
Vitamin D3
n=35 Participants
Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
|
Placebo
n=18 Participants
Women in the placebo group received once capsule of placebo once weekly for eight weeks.
Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks
|
|---|---|---|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Systolic blood pressure before treatment
|
112 mmHG
Standard Error 1.9
|
113 mmHG
Standard Error 2.8
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Systolic blood pressure after treatment
|
108 mmHG
Standard Error 1
|
109 mmHG
Standard Error 2.3
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Diastolic blood pressure before treatment
|
68.4 mmHG
Standard Error 1.1
|
69 mmHG
Standard Error 1.7
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Diastolic blood pressure after treatment
|
67.9 mmHG
Standard Error 1.3
|
67 mmHG
Standard Error 1.6
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Mean arterial pressure before treatment
|
83 mmHG
Standard Error 1.2
|
84 mmHG
Standard Error 1.9
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Mean arterial pressure after treatment
|
81 mmHG
Standard Error 1.1
|
81 mmHG
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment) and 8 weeks later (post-treatment)The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone insulin. The HOMA index was calculated as the product of fasting plasma blood glucose and insulin divided by 22.5.
Outcome measures
| Measure |
Vitamin D3
n=35 Participants
Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
|
Placebo
n=18 Participants
Women in the placebo group received once capsule of placebo once weekly for eight weeks.
Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks
|
|---|---|---|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Insulin resistance (HOMA-IR)before treatment
|
2.07 HOMA IR score
Standard Error 0.37
|
1.58 HOMA IR score
Standard Error 0.3
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Insulin resistance (HOMA-IR) after treatment
|
2.03 HOMA IR score
Standard Error 0.22
|
1.52 HOMA IR score
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment) and 8 weeks later (post-treatment)Free testosterone
Outcome measures
| Measure |
Vitamin D3
n=35 Participants
Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
|
Placebo
n=18 Participants
Women in the placebo group received once capsule of placebo once weekly for eight weeks.
Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks
|
|---|---|---|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Free testosterone before treatment
|
0.59 ng/dL
Standard Error 0.06
|
0.61 ng/dL
Standard Error 0.08
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Free testosterone after treatment
|
0.68 ng/dL
Standard Error 0.06
|
0.68 ng/dL
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment) and 8 weeks later (post-treatment)Lipid profile
Outcome measures
| Measure |
Vitamin D3
n=35 Participants
Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
|
Placebo
n=18 Participants
Women in the placebo group received once capsule of placebo once weekly for eight weeks.
Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks
|
|---|---|---|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
HDL before treatment
|
46 mg/dL
Standard Error 2.4
|
47 mg/dL
Standard Error 2.9
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
HDL after treatment
|
48 mg/dL
Standard Error 2.6
|
50 mg/dL
Standard Error 3.2
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
LDH before treatment
|
106 mg/dL
Standard Error 6.1
|
103 mg/dL
Standard Error 7.7
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
LDL after treatment
|
100 mg/dL
Standard Error 4.1
|
101 mg/dL
Standard Error 5.1
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Total cholesterol before treatment
|
183 mg/dL
Standard Error 6.5
|
179 mg/dL
Standard Error 9
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Total cholesterol after treatment
|
166 mg/dL
Standard Error 11
|
177 mg/dL
Standard Error 6.3
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Triglycerides before treatment
|
138 mg/dL
Standard Error 22
|
113 mg/dL
Standard Error 21
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Triglycerides after treatment
|
117 mg/dL
Standard Error 20
|
98 mg/dL
Standard Error 13
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)Ferriman-Gallwey score is a method used to assess and quantify hirsutism in women. A total score \< 8 is considered normal whereas a score of 8 to 15 indicates mild hirsutism. A score \>15 indicates moderate or severe hirsutism.
Outcome measures
| Measure |
Vitamin D3
n=35 Participants
Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
|
Placebo
n=18 Participants
Women in the placebo group received once capsule of placebo once weekly for eight weeks.
Placebo: Women in the placebo arm received once capsule of placebo once weekly for eight weeks
|
|---|---|---|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Ferriman-Gallwey score before treatment
|
9.8 Scores on a scale
Standard Error 1.5
|
8.1 Scores on a scale
Standard Error 1.4
|
|
The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Ferriman-Gallwey score after treatment
|
8.1 Scores on a scale
Standard Error 1.5
|
7.6 Scores on a scale
Standard Error 1.5
|
Adverse Events
Vitamin D3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place