Clinical trial NCT06139133: The Impact of Vitamin D Supplementation on Pregnant Women With the Risk of GDM
Official title: The Impact of Vitamin D Supplementation on Gestational Diabetes Mellitus Risk in Pakistani Females: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: Gestational Diabetes Mellitus
Pregnancy
High risk women
Vitamin D supplementation
Lead sponsor: IIMC, Riphah International University, Pakistan
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 350
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Gestational diabetes mellitus with 75g OGTT
timeFrame: 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Nadim Akbar Khan, FCPS
role: PRINCIPAL_INVESTIGATOR
References: