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

NCT ID: NCT02328404

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-12-31

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).

Conditions

Polycystic Ovary Syndrome; Hypovitaminosis D

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

vitamin D3 (Biodal 50,000 IU)

50,000 IU Vitamin D3 tablet given orally once weekly for 3 months

Group Type: ACTIVE_COMPARATOR

50,000 IU vitamin D3

Intervention Type: DRUG

Film-coated tablet Biodal 50,000 IU containing cholecalciferol 50,000 IU

placebo

Placebo tablet given orally once weekly for 3 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo film-coated tablet of Biodal 50,000 IU

Interventions

50,000 IU vitamin D3

Film-coated tablet Biodal 50,000 IU containing cholecalciferol 50,000 IU

Intervention Type: DRUG

Placebo

Placebo film-coated tablet of Biodal 50,000 IU

Intervention Type: DRUG

Other Intervention Names

Biodal 50,000 IU; cholecalciferol 50,000 IU; Biodal 50,000IU

Eligibility 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].

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: collaborator

Hayat Pharmaceutical Co. PLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ALA M ABU RUQAA, MSC PHARM

Role: STUDY_DIRECTOR

HAYAT PHARMACEUTICAL INDUSTRIES CO. PLC

Locations

King Abdullah University Hospital

Irbid, Irbid Governorate, Jordan

Countries

Jordan

References

Al-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.

Reference Type: DERIVED

PMID: 33010974 (View on PubMed)

Other Identifiers

2013-003353-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VitD31.0

Identifier Type: -

Identifier Source: org_study_id