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The Impact of Vitamin D Supplementation on Pregnant Women With the Risk of GDM

NCT06139133 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2023-11-29

No results posted yet for this study

Summary

A clinical trial will be conducted in Chemical pathology department in collaboration with Gyne \&Obs department of PRH, IIMC over a period of 02 years w.e.f. December 15, 2023. 350 pregnant women with 07-11 weeks of gestation and having a high risk for GDM with low Vitamin D3 levels and normal response to 75g OGTT will be randomly assigned to receive either vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks or Placebo. These women will be checked for the diagnosis of GDM with 75 g OGTT at 24- 28 weeks of gestation. The outcome of the study will be the incidence of GDM based on the International Association of Diabetes and Pregnancy Study Groups Criteria.

Conditions

  • Gestational Diabetes Mellitus

Interventions

DRUG

Placebo supplementation

Placebo

DRUG

Vitamin D supplementation

Vitamin D3 supplementation (2 00,000 IU/Week)

Sponsors & Collaborators

  • IIMC, Riphah International University, Pakistan

    lead OTHER

Principal Investigators

  • Muhammad Nadim Akbar Khan, FCPS · Riphah International University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Pakistan

Study Locations

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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 NCT06139133 on ClinicalTrials.gov