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

Hayat Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Polycystic Ovary Syndrome

Hypovitaminosis D

Treatments

Drug: Placebo

Drug: 50,000 IU vitamin D3

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02328404

2013-003353-22 (EudraCT Number)

VitD31.0

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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].