The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hayat Pharmaceutical Co. PLC
• Collaborator: Jordan University of Science and Technology
• Treatments: Cholecalciferol; Chromium; Ergocalciferols; Vitamin D; Vitamins

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 < 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].