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

Last updated: November 23, 2023
Sponsor: IIMC, Riphah International University, Pakistan
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Placebo supplementation

Vitamin D supplementation

Clinical Study ID

NCT06139133
Riphah/IIMC/IRC/23/3073
  • Ages 21-40
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant women with 07-11 weeks of gestation
  • 21 - 40 Years age range
  • Pregnant women with high risk for GDM
  • history of GDM in their previous pregnancy,
  • one or more first-degree relative diagnosed with diabetes mellitus,
  • overweight-BMI >25 kg/m2 or obese-BMI >30 kg/m2 at their first antenatal visit
  • with a history of polycystic ovarian syndrome.
  • Pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT
  • Low levels of Vitamin D3 (<30ng/ml)

Exclusion

Exclusion Criteria:

  • Women already diagnosed with diabetes mellitus
  • Any other systemic disease.
  • High risk pregnant women diagnosed with diabetes on the basis of 75g OGTT
  • High risk pregnant women with normal vitamin D3 levels (>30ng/ml).

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Placebo supplementation
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2025

Study Description

Gestational diabetes mellitus is a common condition among pregnant women with metabolic implications for both the mother and offspring. Studies have suggested a potential role of vitamin D status in GDM risk, but evidence from randomized controlled trials is inadequate and inconclusive. A research has been planned to investigate the effect of vitamin D supplementation on GDM development among high risk pregnant women through a well-designed RCT Pregnant women at a risk to develop GDM with low vitamin D levels (<30 ng/mL) at 07-11 weeks of gestation will be recruited and randomly assigned to receive either vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks or placebo. Randomization will be achieved using a computer-generated random sequence or a randomization table. The allocation will be done in a 1:1 ratio, with equal numbers of participants assigned to the vitamin D and placebo groups. The primary outcome will be the incidence of GDM based on the International Association of Diabetes and Pregnancy Study Groups Criteria after 75 g OGTT.

This study will contribute to the understanding of the relationship between vitamin D and GDM risk through a well-designed RCT with integrated approaches. The findings may inform clinical practice and public health recommendations for vitamin D supplementation during pregnancy.

Connect with a study center

  • Pakistan Railway Hospital

    Rawalpindi, Punjab 46000
    Pakistan

    Site Not Available

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