To understand the role of vitamin D supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
274
The intervention arm will receive 400 IU vitamin D3 from routine antenatal multivitamin supplement tablet + 400 IU vitamin D3 daily until delivery.
KK Women's and Children's Hospital
Singapore, Singapore
Change in maternal serum 25OHD concentration
Time frame: Baseline, 26-30 gestational weeks
Change in maternal total cholesterol level
Time frame: Baseline, 26-30 gestational weeks
Change in maternal HDL-cholesterol level
Time frame: Baseline, 26-30 gestational weeks
Change in maternal LDL-cholesterol level
Time frame: Baseline, 26-30 gestational weeks
Change in maternal triglyceride level
Time frame: Baseline, 26-30 gestational weeks
Incidence of preeclampsia
Time frame: up to delivery
Incidence of gestational hypertension
Time frame: Through pregnancy until delivery
Incidence of gestational diabetes
Time frame: Through pregnancy until delivery
Fasting glucose level
Time frame: 24-28 gestational weeks
1-hour post-load glucose level
Time frame: 24-28 gestational weeks
2-hour post-load glucose level
Time frame: 24-28 gestational weeks
Incidence of caesarean section
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Time frame: At delivery
Incidence of preterm birth (<37 weeks)
Time frame: At delivery
Incidence of low birth weight (<2500g)
Time frame: At delivery
Neonatal birth weight (g)
Time frame: At delivery
Neonatal birth length (cm)
Time frame: At delivery
Neonatal head circumference (cm)
Time frame: At delivery
Incidence of admission to special care (including intensive care) during neonatal period
Time frame: Within 28 days after delivery