Phase 3
Completed N=60
The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)
Polycystic Ovary Syndrome · Hypovitaminosis D
Source: ClinicalTrials.gov NCT02328404 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: Ultrasound Examination of Number of Follicles and Ovarian Volume — 7; 0; 5; 11 participants — p=0.001
Summary
This is a prospective double-blind, randomized, parallel-group, placebo-controlled trial designed to examine the effect of supplementation with 50,000 IU vitamin D3 for 3 months on Polycystic Ovary Syndrome (PCOS) prognosis, serum 25-Hydroxy Vitamin D (25(OH)D) level, serum chromium level, insulin resistance, and Body Mass Index (BMI), in 60 overweight Jordanian female patients diagnosed with PCOS and with hypovitaminosis D.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ultrasound Examination of Number of Follicles and Ovarian Volume |
7; 0; 5; 11; 17; 18 | 0.001 sig |
| PRIMARY Menstrual Regularity |
27; 4; 2; 25 | 0.001 sig |
| PRIMARY Hirsutism Score |
11.5; 16.7 | 0.01 sig |
| PRIMARY Serum Progesterone Level |
5.8; 7.3 | 0.65 |
| PRIMARY Total Testosterone Level |
1.6; 1.9 | 0.25 |
| PRIMARY Free Androgen Index |
4.5; 4.4 | 0.04 sig |
| PRIMARY Sex Hormone Binding Globulin Concentration |
85.9; 100.6 | 0.02 sig |
| SECONDARY Serum 25-Hydroxy Vitamin D3 Level |
48.2; 11.8 | <0.000 sig |
| SECONDARY Serum Chromium Concentration |
0.27; 0.27 | 0.67 |
| SECONDARY Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment |
6.9; 6.4 | 0.51 |
| SECONDARY Body Mass Index |
25.6; 26.5 | 0.08 |
| SECONDARY Serum Parathyroid Hormone Concentration |
39.1; 52.6 | 0.01 sig |
| SECONDARY Serum Calcium Concentration |
2.3; 2.3 | 0.89 |
| SECONDARY Serum Phosphorous Concentration |
1.2; 1.2 | 0.60 |
| SECONDARY Serum C-Reactive Protien Concentration |
5.4; 3.9 | 0.35 |
Eligibility Criteria
Inclusion Criteria
- Female gender.
- Aged between 18 and 49 years old.
- Ethnic group (Caucasian, Middle-eastern).
- Overweight (BMI 25-30 kg^m2).
- Diagnosed with Polycystic ovary syndrome according to Rotterdam criteria (Rotterdam SHRE-ASRM Sponsored Polycystic ovary syndrome consensus workshop group, 2004).
- Diagnosed with hypovitaminosis D (serum 25(OH)D level 49 years old.
- Underweight, normal body weight ,Body Mass Index (BMI) 30 kg/m2)
- Diagnosis with type 1 or type 2 diabetes mellitus, hypothyroidism, hyperthyroidism, liver disease, renal dysfunction, cardiovascular diseases, androgen-secreting tumor, Cushing syndrome, congenital adrenal hyperplasia, hyperprolactinemia, and/or virilism.
- Known history or presence of food allergies or intolerance (e.g dairy products or gluten-containing foods), or any known condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History of drug or alcohol abuse, smoking of 10 cigarettes or more (or equivalent) per day.
- Participants who took medications known to affect metabolic parameters, such as metformin and corticosteroid drugs, vitamin D and calcium.
- Adequate dietary intake of vitamin D (600 IU/day or 15μg/day or more).
- Participation in another clinical or bioequivalence study within 90 days prior to the start of this study period.
- Participants with abnormal Electrocardiogram (ECG).
- Participants with any abnormal laboratory results excluding [ 25(OH)D, Creatinine (Cr), Calcium (Ca), phosphorus (PO4), C-reactive protein(CRP) , triglyceride , High Density Lipoprotien Cholesterol (HDL-C), Low Density Lipoprotien Cholesterol (LDL-C), total cholesterol (TC)/HDL-C ratio, fasting insulin , fasting blood glucose, oral glucose tolerance test, impaired glucose tolerance, Progesterone, total testosterone, sex hormone binding globulin, parathyroid hormone and free androgen index].
Data sourced from ClinicalTrials.gov (NCT02328404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.