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

NCT ID: NCT06139133

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational Diabetes Mellitus; Pregnancy; High risk women; Vitamin D supplementation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Placebo supplementation Group

Pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT but with low levels of Vitamin D3 (\<30ng/ml) will be included. The study subjects will be randomly assigned to receive placebo until delivery.

Group Type: PLACEBO_COMPARATOR

Placebo supplementation

Intervention Type: DRUG

Placebo

Vitamin D supplementation group

pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT but with low levels of Vitamin D3 (\<30ng/ml) will be included for Vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 week. The study subjects will be randomly assigned to receive vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks.

Group Type: EXPERIMENTAL

Vitamin D supplementation

Intervention Type: DRUG

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

Interventions

Placebo supplementation

Placebo

Intervention Type: DRUG

Vitamin D supplementation

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

Intervention Type: DRUG

Eligibility Criteria

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 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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IIMC, Riphah International University, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Nadim Akbar Khan, FCPS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Pakistan Railway Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Muhammad Nadim Akbar Khan, FCPS

Role: CONTACT

Phone: +923005190704

Email: nadeem.akbar@riphah.edu.pk

Facility Contacts

Prof. Saaadia Sultana, FCPS

Role: primary

Other Identifiers

Riphah/IIMC/IRC/23/3073

Identifier Type: -

Identifier Source: org_study_id