Synergistic Effects of Vitamin D and Calcium Supplementation on Hyperglycemia and Dyslipidemia in Patients With Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fasting plasma glucose (FPG) levels
研究概览
简要总结
Gestational diabetes mellitus (GDM) is becoming more common globally as a metabolic disease that occurs during pregnancy and influences the mother and the fetus. It has been linked to preeclampsia, C-section, and a higher lifetime risk of developing type 2 diabetes both for mother and the child. Another complication of GDM is dyslipidemia that also accentuates cardiovascular risks, so the care of lipid profiles is essential for the best pregnancy outcomes. The previous literature review indicates that micronutrients including vitamin D and calcium have a bearing on glucose and lipid profiles. Various studies have established that vitamin D improves the insulin response and lipid profile whereas calcium is vital in insulin and glucose homeostasis. Furthermore, it is revealed that calcium induces vitamin D so that it could undergo its full metabolic effect. Hence, the addition of vitamin D and calcium together may enhance glycemic management and lipid profiles of GDM patients. The aim of the present work is to compare the impact of vitamin D and calcium supplementation on lipid profiles and hyperglycemia in GDM patients. It will measure the major metabolic indices fasting plasma glucose, glycated hemoglobin (HbA1c) and lipid profile (LDL, HDL triglycerides) and review the effect of this on pregnancy outcomes. These outcomes will be assessed by a randomized-controlled trial.
详细描述
A randomized controlled trial study design will be used to assess the efficacy of vitamin D and calcium supplementation in lipid profiles and glycemic index among women with GDM.
The sample for the study will consist of 60 pregnant women diagnosed with GDM, aged 18-40 years, and between 24-28 weeks of gestation. Recruitment of participants will be done in antenatal clinics linked to [Lady Willingdon Hospital Lahore]. The diagnosis of GDM will be performed according to the results of OGTT following the international criteria.
Participants will be randomly divided to one of two groups:
- Intervention Group: This group will receive 600 IU of vitamin D3 and 1.5-2 g of calcium daily for 6 weeks.
- Control Group: This group will receive a placebo containing no active ingredients.
For randomization, a computer-generated sequence will be used to randomly assign participant into the intervention arm or the placebo arm. The study will be conducted as double blind; the participants and the researchers shall not know the group allocations.
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)
盲法说明
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 18-40 years.
- •Gestational age between 24-28 weeks.
- •Diagnosis of GDM based on OGTT results.
- •Willingness of participants to provide written informed consent.
排除标准
- •Pre-existing diabetes mellitus (type 1 or type 2).
- •Chronic kidney or liver disease.
- •Use of vitamin D or calcium supplements in the last 3 months.
- •Multiple pregnancies (twins, triplets).
- •Any major pregnancy complications (e.g., preeclampsia).
研究组 & 干预措施
Arm and Interventions
Experimental: Vitamin D3 and calcium This group will be receive vitamin D3 600 IU and 1.5 g of calcium. This treatment will be conducted for 6 week per day after meal.
干预措施: vitamin D3 (Dietary Supplement)
Arm and placebo
: This group will receive a placebo containing no active ingredients and it will conducted for 6 weeks per day.
干预措施: vitamin D3 (Dietary Supplement)
结局指标
主要结局
Fasting plasma glucose (FPG) levels
时间窗: 6 weeks
fasting plasma glucose measures your blood sugar level post meal after at least 8 hours
HbA1C
时间窗: 6 weeks
HbA1C measure glucose level in past 2 to 3 months
次要结局
- lipid profile(6 weeks)