Clinical trial NCT04841265: The Effect of Vitamin D Supplementation in Overweight and Obese Pregnant Women
Official title: The Effect of Vitamin D Supplementation in Overweight and Obese Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Vitamin D supplementation
Lipid profile
Vitamin D status
Birth outcomes
Pregnancy complications
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-12
Enrollment: 274
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in maternal serum 25OHD concentration
timeFrame: Baseline, 26-30 gestational weeks
measure: Change in maternal total cholesterol level
timeFrame: Baseline, 26-30 gestational weeks
measure: Change in maternal HDL-cholesterol level
timeFrame: Baseline, 26-30 gestational weeks
measure: Change in maternal LDL-cholesterol level
timeFrame: Baseline, 26-30 gestational weeks
measure: Change in maternal triglyceride level
timeFrame: Baseline, 26-30 gestational weeks
Secondary outcomes:
measure: Incidence of preeclampsia
timeFrame: up to delivery
measure: Incidence of gestational hypertension
timeFrame: Through pregnancy until delivery
measure: Incidence of gestational diabetes
timeFrame: Through pregnancy until delivery
measure: Fasting glucose level
timeFrame: 24-28 gestational weeks
measure: 1-hour post-load glucose level
timeFrame: 24-28 gestational weeks
measure: 2-hour post-load glucose level
timeFrame: 24-28 gestational weeks
measure: Incidence of caesarean section
timeFrame: At delivery
measure: Incidence of preterm birth (<37 weeks)
timeFrame: At delivery
measure: Incidence of low birth weight (<2500g)
timeFrame: At delivery
measure: Neonatal birth weight (g)
timeFrame: At delivery
measure: Neonatal birth length (cm)
timeFrame: At delivery
measure: Neonatal head circumference (cm)
timeFrame: At delivery
measure: Incidence of admission to special care (including intensive care) during neonatal period
timeFrame: Within 28 days after delivery
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Dr Loy See Ling, PhD
role: PRINCIPAL_INVESTIGATOR
References: