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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gestational Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo supplementation; Drug: Vitamin D supplementation

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.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Nadim Akbar Khan, FCPS; Phone Number: +923005190704; Email: nadeem.akbar@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Pakistan Railway Hospital
      • Contact: Prof. Saaadia Sultana, FCPS; Phone Number: +923005051033; Email: saadia.sultana@riphah.edu.pk
      • Principal Investigator: Shazia Qayyum, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: Placebo supplementation; Placebo
Experimental: 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.	Drug: Vitamin D supplementation; Vitamin D3 supplementation (2 00,000 IU/Week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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/dlTHE WHO GUIDELINES (2018)	28 weeks

Collaborators and Investigators

• Sponsor: IIMC, Riphah International University, Pakistan
• Investigators: Principal Investigator: Muhammad Nadim Akbar Khan, FCPS, Riphah International University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy; Vitamin D supplementation; High risk women; Gestational Diabetes Mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: Riphah/IIMC/IRC/23/3073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No