The Effect of Vitamin D Supplementation in Overweight and Obese Pregnant Women
- Conditions
- Overweight and Obesity
- Interventions
- Dietary Supplement: Vitamin D3
- Registration Number
- NCT04841265
- Lead Sponsor
- KK Women's and Children's Hospital
- Brief Summary
To understand the role of vitamin D supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 274
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D3 Vitamin D3 The Vitamin D3 (intervention) arm will receive a total of 800 IU vitamin D3 supplementation per day.
- Primary Outcome Measures
Name Time Method Change in maternal serum 25OHD concentration Baseline, 26-30 gestational weeks Change in maternal LDL-cholesterol level Baseline, 26-30 gestational weeks Change in maternal HDL-cholesterol level Baseline, 26-30 gestational weeks Change in maternal total cholesterol level Baseline, 26-30 gestational weeks Change in maternal triglyceride level Baseline, 26-30 gestational weeks
- Secondary Outcome Measures
Name Time Method 1-hour post-load glucose level 24-28 gestational weeks 2-hour post-load glucose level 24-28 gestational weeks 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 Incidence of caesarean section At delivery
Trial Locations
- Locations (1)
KK Women's and Children's Hospital
🇸🇬Singapore, Singapore