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临床试验/NCT04841265
NCT04841265已完成不适用

The Effect of Vitamin D Supplementation in Overweight and Obese Pregnant Women

KK Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2021年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
274
试验地点
1
主要终点
Change in maternal serum 25OHD concentration

研究概览

简要总结

To understand the role of vitamin D supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.

详细描述

The effects of vitamin D supplementation on pregnancy outcomes and metabolic status of overweight and obese pregnant women remain uncertain. In particular, the dosage of vitamin D supplementation has not been defined in this high risk group of women. This study aims to examine whether oral supplement of vitamin D3 (cholecalciferol) in total dosage of 800 IU(prenatal multivitamin containing 400 IU vitamin D3 + 400 IU vitamin D3 alone) given to overweight and obese pregnant women since early pregnancy until delivery can improve maternal and neonatal outcomes, compared with those given prenatal multivitamin containing 400 IU vitamin D3 supplementation, a commonly given antenatal supplement in Singapore. The investigators' hypothesis is that higher dose vitamin D supplementation would lead to better outcomes in overweight and obese pregnant women. The investigators will conduct a two-arm, parallel non-blinded randomized controlled trial. Women with body mass index ≥25kg/m2 will be randomly assigned into groups with a 1:1 randomization ratio, receiving either 800 or 400 IU vitamin D3 supplementation. The study will be conducted at the antenatal clinics, KK Women's and Children's Hospital, Singapore. Measurements of serum 25-hydroxyvitamin D (25OHD), lipid profile and lifestyles information will be taken for all women at baseline (≤16 weeks gestation) and after three months of intervention (26-30 weeks gestation). All women will continue with the vitamin D3 supplementation until delivery. Primary outcomes include levels of maternal serum 25OHDconcentration and lipid profile at 26-30 gestation weeks as compared with the controls, adjusting for baseline measurements. Secondary outcomes include preeclampsia, gestational hypertension, gestational diabetes, glycaemic levels, caesarean section, gestational weight gain, preterm birth, low birth weight and small-for-gestational-age. This study will fill up the gap of knowledge regarding the role of vitamin D supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestation ≤16weeks (16 weeks + 6 days) upon intervention
  • Pre-pregnancy BMI ≥25 kg/m2
  • Aged 21-45 years
  • Willing and able to provide written, informed consent

排除标准

  • Having current or past hypo/hyperparathyroidism, hypercalciuria, hypercalcemia or osteomalacia
  • History of renal disease (including kidney stones and etc.), liver dysfunction, tuberculosis or sarcoidosis
  • Pre-existing diabetes mellitus or chronic hypertension
  • Taking lipid-lowering medicine
  • Gestational diabetes (as confirmed by oral glucose tolerance test) or gestational hypertensive disorder
  • Multiple pregnancy

结局指标

主要结局

Change in maternal serum 25OHD concentration

时间窗: Baseline, 26-30 gestational weeks

Change in maternal LDL-cholesterol level

时间窗: Baseline, 26-30 gestational weeks

Change in maternal HDL-cholesterol level

时间窗: Baseline, 26-30 gestational weeks

Change in maternal total cholesterol level

时间窗: Baseline, 26-30 gestational weeks

Change in maternal triglyceride level

时间窗: Baseline, 26-30 gestational weeks

次要结局

  • 1-hour post-load glucose level(24-28 gestational weeks)
  • 2-hour post-load glucose level(24-28 gestational weeks)
  • Incidence of caesarean section(At delivery)
  • Neonatal birth length (cm)(At delivery)
  • Incidence of preterm birth (<37 weeks)(At delivery)
  • Neonatal birth weight (g)(At delivery)
  • Neonatal head circumference (cm)(At delivery)
  • Incidence of gestational diabetes(Through pregnancy until delivery)
  • Fasting glucose level(24-28 gestational weeks)
  • Incidence of preeclampsia(up to delivery)
  • Incidence of gestational hypertension(Through pregnancy until delivery)
  • Incidence of low birth weight (<2500g)(At delivery)
  • Incidence of admission to special care (including intensive care) during neonatal period(Within 28 days after delivery)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Loy See Ling

Senior Research Fellow

KK Women's and Children's Hospital

研究点 (1)

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