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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Drug: Placebo supplementation
* Drug: Vitamin D supplementation


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo supplementation Group<br>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<br>* Placebo<br>|
| Experimental: Vitamin D supplementation group<br>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<br>* Vitamin D3 supplementation (2 00,000 IU/Week)<br>|

What is the study measuring?
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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/dl THE WHO GUIDELINES (2018) | 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Gestational Diabetes Mellitus, Vitamin D supplementation, High risk women