--- title: The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS) nct_id: NCT02328404 overall_status: COMPLETED phase: PHASE3 sponsor: Hayat Pharmaceutical Co. PLC study_type: INTERVENTIONAL primary_condition: Polycystic Ovary Syndrome countries: Jordan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02328404.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02328404" ct_last_update_post_date: 2016-08-04 last_seen_at: "2026-05-12T07:28:33.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS) **Official Title:** The Effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance Among Overweight Jordanian Women With Polycystic Ovary Syndrome in Irbid **NCT ID:** [NCT02328404](https://clinicaltrials.gov/study/NCT02328404) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 60 - **Lead Sponsor:** Hayat Pharmaceutical Co. PLC - **Collaborators:** Jordan University of Science and Technology - **Conditions:** Polycystic Ovary Syndrome, Hypovitaminosis D - **Start Date:** 2014-02 - **Completion Date:** 2014-12 - **CT.gov Last Update:** 2016-08-04 ## Brief 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. ## Detailed Description This study is designed to assess the safety and efficacy of 50,000 IU vitamin D supplementation once weekly for 3 months on improvement in PCOS prognosis and improvement in serum 25(OH)D levels in 60 overweight Jordanian females (defined as having a BMI 25-30kg/m2), diagnosed with PCOS (based on Rotterdam criteria), and with hypovitaminosis D (defined as a serum 25(OH)D level \< 20 ng/mL), compared with placebo. Evaluation of the safety and efficacy of the dosing regimen will be conducted over 6 study visits during which clinical and biochemical signs of PCOS as well as serum 25(OH)D level, serum chromium level, insulin resistance, and BMI will be evaluated. The measurements will be collected as follows : day (-7) during screening , Day (0) base line measurements , Day (30) , Day(60), Day (90), day (104). ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 49 Years - **Sex:** FEMALE - **Healthy Volunteers:** Yes ``` 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 \[ 25(OH)D, Creatinine (Cr), Calcium (Ca), phosphorus (PO4), C-reactive protein(CRP) , triglyceride , High Density Lipoprotien Cholesterol (HDL-C), Low Density Lipoprotien Cholesterol (LDL-C), total cholesterol (TC)/HDL-C ratio, fasting insulin , fasting blood glucose, oral glucose tolerance test, impaired glucose tolerance, Progesterone, total testosterone, sex hormone binding globulin, parathyroid hormone and free androgen index\]. ``` ## Arms - **vitamin D3 (Biodal 50,000 IU)** (ACTIVE_COMPARATOR) — 50,000 IU Vitamin D3 tablet given orally once weekly for 3 months - **placebo** (PLACEBO_COMPARATOR) — Placebo tablet given orally once weekly for 3 months ## Interventions - **50,000 IU vitamin D3** (DRUG) — Film-coated tablet Biodal 50,000 IU containing cholecalciferol 50,000 IU - **Placebo** (DRUG) — Placebo film-coated tablet of Biodal 50,000 IU ## Primary Outcomes - **Ultrasound Examination of Number of Follicles and Ovarian Volume** _(time frame: 3 months)_ — Evaluation of the efficacy of the dosing regimen as per the approved Summery of Product Characteristics (SmPC) (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis clinically using ultrasound examination. In this measure the reported results were the finding of the ultrasound examination after the course of the treatment /intervention as per the study protocol and reporting the numbers of patients with normal ovaries, One normal ovary and the other is polycystic or both ovaries are poly-cystic. An improvement in PCOS prognosis clinically by ultrasound examination is defined by: * decreasing the number of follicles to \< 12 follicles measuring 2-9 mm in diameter * decreasing ovarian volume to \< 10 cm3 - **Menstrual Regularity** _(time frame: 3 months)_ — Evaluation of the efficacy of the dosing regimen as per the approved SmPC (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis by assessment of menstrual regularity An improvement in PCOS prognosis by assessment of menstrual regularity is measured through improving progesterone level \> 4 ng/mL. One of the clinical signs of improving PCOS prognosis is menstrual cycle regularity. In this measure ,the reported results consist of the number of volunteers/patients in each arm either with regular menstrual cycle or irregular menstrual cycle after completing the course of the treatment/ intervention as per the study protocol. The results will be statistically analyzed using paired student t-test and 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. - **Hirsutism Score** _(time frame: 3 months)_ — The scale ranges between 0 and 36, where A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961).Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS prognosis by evaluating Hirsutism Score.Hirsutism score was assessed using self-administrated Ferriman-Gallwey scoring system (Ferriman and Gallwey, 1961). Each participant answered the hirsutism test with the help of a trained nurse who was working in the same clinic. The score of each body site may range between 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth). In this measure , the hirsutism score were reported in each are after completing the course of treatment/ intervention as per the study protocol. after which, the means were compared for statistical significance between the two groups / arms. - **Serum Progesterone Level** _(time frame: 3 months)_ — The results below show the Serum Progesterone level after treatment in each arm after completing the course of the treatment / intervention as per the study protocol.after which, the means were compared for statistical significance between the two groups / arms. After which, the means were compared for statistical significance between the two groups / arms. The evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Serum Progesterone level. One of the clinical signs of improving PCOS prognosis is the change in progesterone level. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. - **Total Testosterone Level** _(time frame: 3 months)_ — Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Total Testosterone level before and after the treatment. In this measure , the Total Testosterone levels in each arm were reported after completing the course of the treatment / intervention as per the study protocol. One of the clinical signs of improving PCOS prognosis is the change in testosterone level. After which, the means were compared for statistical significance between the two groups / arms. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. - **Free Androgen Index** _(time frame: 3 months)_ — Free Androgen Index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG). In this measure , the Free Androgen Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms. Improvement assessment of PCOS Prognosis by evaluating the change in Free Androgen Index. One of the clinical signs of improving PCOS prognosis is the change in FAI. the results will be statistically analyzed using Wilcoxon (Mann- Whitney) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. - **Sex Hormone Binding Globulin Concentration** _(time frame: 3 months)_ — Evaluation of Biodal 50,000 IU on improvement of PCOS Prognosis by comparing the Sex Hormone Binding Globulin concentrations in both groups/arms. One of the clinical signs of improving PCOS prognosis is the change in the Sex Hormone Binding Globulin Concentration. In this measure , the Sex Hormone Binding Globulin Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms. The results will be statistically analyzed using Wilcoxon (Mann-Whiteny) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. ## Secondary Outcomes - **Serum 25-Hydroxy Vitamin D3 Level** _(time frame: 3 months)_ - **Serum Chromium Concentration** _(time frame: 3 months)_ - **Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment** _(time frame: 3 months)_ - **Body Mass Index** _(time frame: 3 months)_ - **Serum Parathyroid Hormone Concentration** _(time frame: 3 months)_ - **Serum Calcium Concentration** _(time frame: 3 months)_ - **Serum Phosphorous Concentration** _(time frame: 3 months)_ - **Serum C-Reactive Protien Concentration** _(time frame: 3 months)_ ## Locations (1) - King Abdullah University Hospital, Irbid, Irbid Governorate, Jordan ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.king abdullah university hospital|irbid|irbid governorate|jordan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02328404.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02328404* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*