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

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

Detailed Description
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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.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D3<br>The Vitamin D3 (intervention) arm will receive a total of 800 IU vitamin D3 supplementation per day. | Dietary Supplement: Vitamin D3<br>* The intervention arm will receive 400 IU vitamin D3 from routine antenatal multivitamin supplement tablet + 400 IU vitamin D3 daily until delivery.<br>|
| No Intervention: Control<br>The control arm will receive 400 IU vitamin D3 per day from routine antenatal multivitamin supplementation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maternal serum 25OHD concentration |  | Baseline, 26-30 gestational weeks | 
| Change in maternal total cholesterol level |  | Baseline, 26-30 gestational weeks | 
| Change in maternal HDL-cholesterol level |  | Baseline, 26-30 gestational weeks | 
| Change in maternal LDL-cholesterol level |  | Baseline, 26-30 gestational weeks | 
| Change in maternal triglyceride level |  | Baseline, 26-30 gestational weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of preeclampsia |  | up to delivery | 
| Incidence of gestational hypertension |  | Through pregnancy until delivery | 
| Incidence of gestational diabetes |  | Through pregnancy until delivery | 
| Fasting glucose level |  | 24-28 gestational weeks | 
| 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 | 
| Incidence of preterm birth (<37 weeks) |  | At delivery | 
| Incidence of low birth weight (<2500g) |  | At delivery | 
| Neonatal birth weight (g) |  | At delivery | 
| Neonatal birth length (cm) |  | At delivery | 
| Neonatal head circumference (cm) |  | At delivery | 
| Incidence of admission to special care (including intensive care) during neonatal period |  | Within 28 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D supplementation, Lipid profile, Vitamin D status, Birth outcomes, Pregnancy complications