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The Effects of Vitamin D on Angiogenic Factors in Women With Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT02460380
Recruitment Status : Completed
First Posted : June 2, 2015
Results First Posted : September 14, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Grazi, Maimonides Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Polycystic Ovary Syndrome
Vitamin D Deficiency
Interventions Drug: Vitamin D3
Other: Placebo
Enrollment 93
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 45 23
Completed 35 18
Not Completed 10 5
Reason Not Completed
Withdrawal by Subject             10             5
Arm/Group Title Vitamin D3 Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 45 23 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 18 participants 53 participants
30.5  (6.4) 29.6  (7.6) 30.2  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 18 participants 53 participants
Female
35
 100.0%
18
 100.0%
53
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 23 participants 68 participants
Hispanic or Latino
31
  68.9%
17
  73.9%
48
  70.6%
Not Hispanic or Latino
14
  31.1%
6
  26.1%
20
  29.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 35 participants 18 participants 53 participants
35
 100.0%
18
 100.0%
53
 100.0%
1.Primary Outcome
Title Effect of Vitamin D on Angiogenic Factors
Hide Description Serum TGF-β1/sENG ratio as a measure of TGF-β1 bioavailability
Time Frame Baseline (pre-treatment) and 8 weeks later (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 35 18
Mean (Standard Error)
Unit of Measure: ratio
Serum TGF-β1/sENG before treatment 6.7  (0.4) 5.6  (0.5)
Serum TGF-β1/sENG after treatment 5.9  (0.4) 5.5  (0.4)
2.Primary Outcome
Title Effect of Vitamin D on Angiogenic Factors
Hide Description Serum VEGF level
Time Frame Baseline (pre-treatment) and 8 weeks later (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 35 18
Mean (Standard Error)
Unit of Measure: pg/mL
Serum VEGF level before treatment 1106.4  (36.5) 893.1  (90.2)
Serum VEGF level after treatment 965.3  (42.7) 866  (70.8)
3.Secondary Outcome
Title The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Hide Description Interval between periods as a measure ovulatory dysfunction
Time Frame Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 35 18
Mean (Standard Error)
Unit of Measure: Days
Interval between periods before treatment 80.2  (9.8) 79  (9)
Interval between periods after treatment 60  (6.7) 75  (9)
4.Secondary Outcome
Title The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Hide Description Blood pressure
Time Frame Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 35 18
Mean (Standard Error)
Unit of Measure: mmHG
Systolic blood pressure before treatment 112  (1.9) 113  (2.8)
Systolic blood pressure after treatment 108  (1) 109  (2.3)
Diastolic blood pressure before treatment 68.4  (1.1) 69  (1.7)
Diastolic blood pressure after treatment 67.9  (1.3) 67  (1.6)
Mean arterial pressure before treatment 83  (1.2) 84  (1.9)
Mean arterial pressure after treatment 81  (1.1) 81  (1.7)
5.Secondary Outcome
Title The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Hide Description 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.
Time Frame Baseline (pre-treatment) and 8 weeks later (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D3 Group Before Treatment Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 35 18
Mean (Standard Error)
Unit of Measure: HOMA IR score
Insulin resistance (HOMA-IR)before treatment 2.07  (0.37) 1.58  (0.3)
Insulin resistance (HOMA-IR) after treatment 2.03  (0.22) 1.52  (0.24)
6.Secondary Outcome
Title The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Hide Description Free testosterone
Time Frame Baseline (pre-treatment) and 8 weeks later (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 35 18
Mean (Standard Error)
Unit of Measure: ng/dL
Free testosterone before treatment 0.59  (0.06) 0.61  (0.08)
Free testosterone after treatment 0.68  (0.06) 0.68  (0.11)
7.Secondary Outcome
Title The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Hide Description Lipid profile
Time Frame Baseline (pre-treatment) and 8 weeks later (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 35 18
Mean (Standard Error)
Unit of Measure: mg/dL
HDL before treatment 46  (2.4) 47  (2.9)
HDL after treatment 48  (2.6) 50  (3.2)
LDH before treatment 106  (6.1) 103  (7.7)
LDL after treatment 100  (4.1) 101  (5.1)
Total cholesterol before treatment 183  (6.5) 179  (9)
Total cholesterol after treatment 166  (11) 177  (6.3)
Triglycerides before treatment 138  (22) 113  (21)
Triglycerides after treatment 117  (20) 98  (13)
8.Secondary Outcome
Title The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
Hide Description 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.
Time Frame Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 35 18
Mean (Standard Error)
Unit of Measure: Scores on a scale
Ferriman-Gallwey score before treatment 9.8  (1.5) 8.1  (1.4)
Ferriman-Gallwey score after treatment 8.1  (1.5) 7.6  (1.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vitamin D3 Placebo
Hide Arm/Group Description

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.

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

All-Cause Mortality
Vitamin D3 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vitamin D3 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vitamin D3 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/18 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mohamad Irani
Organization: Maimonides Medical Center
Phone: 3472862167
Responsible Party: Richard Grazi, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT02460380     History of Changes
Other Study ID Numbers: 2013-06-03
First Submitted: May 23, 2015
First Posted: June 2, 2015
Results First Submitted: February 6, 2017
Results First Posted: September 14, 2018
Last Update Posted: October 12, 2018