Clinical trial · Interventional
The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)
The Effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance Among Overweight Jordanian Women With Polycystic Ovary Syndrome in Irbid
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypovitaminosis D | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 50,000 IU vitamin D3 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- vitamin D3 (Biodal 50,000 IU)
- description
- 50,000 IU Vitamin D3 tablet given orally once weekly for 3 months
- interventionNames
- Drug: 50,000 IU vitamin D3
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Placebo tablet given orally once weekly for 3 months
- interventionNames
- Drug: Placebo
Primary outcomes (7)
- measure
- Ultrasound Examination of Number of Follicles and Ovarian Volume
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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 \< 20 ng/mL). * Inadequate dietary intake of vitamin D (\<600 IU/day or \<15μg/day). * Physical examination being assessed and accepted by the attending physician. * Systolic blood pressure within the normal range (90-140 mmHg). * Diastolic blood pressure within the normal range (60-90 mmHg). * Heart rate within the normal range (60-100 BPM). * Oral body temperature within the normal range (35.9 - 37.6 Cᵒ). * Normal complete blood count , Liver Function enzymes test , Aspartate Transaminase (AST) , Alanine Transaminase (ALT) and Kidney function tests , Blood Urea Nitrogen (BUN) and Serum Creatinine (SrCr). * Participant is willing and able to give informed consent for participation in the study. * Able and willing to comply with all study requirements. Exclusion Criteria: * Female participants who are pregnant, lactating or planning pregnancy during the course of the study. * Ethnic group: non Caucasian. * Females aged \<18 or \>49 years old. * Underweight, normal body weight ,Body Mass Index (BMI) \< 25 kg\^m2 * Obese or morbidly obese (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 \[ 25(OH)D, Creatinine (Cr), Calcium (Ca), phosphorus (PO4), C-reactive protein(CRP) , triglyceride , High Density Lipoprotien Cholesterol (HDL-C), Low Density Lipoprotien Cholesterol (LDL-C), total cholesterol (TC)/HDL-C ratio, fasting insulin , fasting blood glucose, oral glucose tolerance test, impaired glucose tolerance, Progesterone, total testosterone, sex hormone binding globulin, parathyroid hormone and free androgen index\].
References
Publications (1)
- DERIVEDAl-Bayyari N, Al-Domi H, Zayed F, Hailat R, Eaton A. Androgens and hirsutism score of overweight women with polycystic ovary syndrome improved after vitamin D treatment: A randomized placebo controlled clinical trial. Clin Nutr. 2021 Mar;40(3):870-878. doi: 10.1016/j.clnu.2020.09.024. Epub 2020 Sep 24. PMID 33010974