The Impact of Vitamin D Supplementation on Pregnant Women With the Risk of GDM
- Conditions
- Gestational Diabetes Mellitus
- Interventions
- Drug: Placebo supplementation
- Registration Number
- NCT06139133
- Lead Sponsor
- IIMC, Riphah International University, Pakistan
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 350
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo supplementation Group Placebo supplementation 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. Vitamin D supplementation group Vitamin D supplementation 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.
- Primary Outcome Measures
Name Time Method Gestational diabetes mellitus with 75g OGTT 28 weeks 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pakistan Railway Hospital
🇵🇰Rawalpindi, Punjab, Pakistan