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

NCT02328404 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-08-04

Study results available
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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.

Conditions

  • Polycystic Ovary Syndrome
  • Hypovitaminosis D

Interventions

DRUG

50,000 IU vitamin D3

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

DRUG

Placebo

Placebo film-coated tablet of Biodal 50,000 IU

Sponsors & Collaborators

  • Jordan University of Science and Technology

    collaborator OTHER

  • Hayat Pharmaceutical Co. PLC

    lead INDUSTRY

Principal Investigators

  • ALA M ABU RUQAA, MSC PHARM · HAYAT PHARMACEUTICAL INDUSTRIES CO. PLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • Jordan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02328404 on ClinicalTrials.gov