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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Vitamin D3

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.

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjarat Oh; Phone Number: 83684641; Email: benjarat.oh@kkh.com.sg
• Study Contact Backup: Name: Si Xuan Rachael Loo; Phone Number: 82990112; Email: rachael.loo.s.x@kkh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Dr Loy See Ling, PhD, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): April 11, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Lipid profile; Pregnancy complications; Vitamin D supplementation; Birth outcomes; Vitamin D status
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: CIRB 2021/2055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No