The Impact of Vitamin D Supplementation on Gestational Diabetes Mellitus Risk in Pakistani Females: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Gestational diabetes mellitus with 75g OGTT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Placebo supplementation (Drug)
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.
干预措施: Vitamin D supplementation (Drug)
结局指标
主要结局
Gestational diabetes mellitus with 75g OGTT
时间窗: 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)
次要结局
未报告次要终点