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

Gestational Diabetes Mellitus Clinical Trial

Official title:

The Impact of Vitamin D Supplementation on Gestational Diabetes Mellitus Risk in Pakistani Females: A Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06139133
• Other study ID #: Riphah/IIMC/IRC/23/3073
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: IIMC, Riphah International University, Pakistan
• Contact: Muhammad Nadim Akbar Khan, FCPS
• Phone: +923005190704
• Email: nadeem.akbar[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Drug:
• Placebo supplementation
Placebo
• Vitamin D supplementation
Vitamin D3 supplementation (2 00,000 IU/Week)

Locations

Country	Name	City	State
Pakistan	Pakistan Railway Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
IIMC, Riphah International University, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational diabetes mellitus with 75g OGTT	75g-OGTT is an oral glucose tolerance test done by ingesting 75 g glucose dissolved in water in the morning at 7- 8 am.; Patient seated quietly & relaxed for 30 mins before taking the test; A zero-time (baseline) blood sample is drawn; The patient is then given a 75-g glucose solution to drink within 5 minutes; 2nd Sample - 1h after consumption of sugar to measure the blood glucose; 3rd Sample- 2h after consumption of sugar to measure blood glucose; Both blood samples should be kept in fluoride-containing collection tubes; Interpretation of Test: GDM diagnosed if any one of the following is present after 75g OGTT: FPG: >92 mg/dl; 1-hour PG: >180 mg/dl; 2-hour PG: >153 mg/dl; THE WHO GUIDELINES (2018)	28 weeks