Overview

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].