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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04841265
• Other study ID #: CIRB 2021/2055
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: March 2024

Study information

• Verified date: October 2023
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 274
• Est. completion date: March 2024
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maternal serum 25OHD concentration		Baseline, 26-30 gestational weeks
Primary	Change in maternal total cholesterol level		Baseline, 26-30 gestational weeks
Primary	Change in maternal HDL-cholesterol level		Baseline, 26-30 gestational weeks
Primary	Change in maternal LDL-cholesterol level		Baseline, 26-30 gestational weeks
Primary	Change in maternal triglyceride level		Baseline, 26-30 gestational weeks
Secondary	Incidence of preeclampsia		up to delivery
Secondary	Incidence of gestational hypertension		Through pregnancy until delivery
Secondary	Incidence of gestational diabetes		Through pregnancy until delivery
Secondary	Fasting glucose level		24-28 gestational weeks
Secondary	1-hour post-load glucose level		24-28 gestational weeks
Secondary	2-hour post-load glucose level		24-28 gestational weeks
Secondary	Incidence of caesarean section		At delivery
Secondary	Incidence of preterm birth (<37 weeks)		At delivery
Secondary	Incidence of low birth weight (<2500g)		At delivery
Secondary	Neonatal birth weight (g)		At delivery
Secondary	Neonatal birth length (cm)		At delivery
Secondary	Neonatal head circumference (cm)		At delivery
Secondary	Incidence of admission to special care (including intensive care) during neonatal period		Within 28 days after delivery