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

NCT ID: NCT04841265

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2024-03-31

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Vitamin D3

The Vitamin D3 (intervention) arm will receive a total of 800 IU vitamin D3 supplementation per day.

Group Type: ACTIVE_COMPARATOR

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

The intervention arm will receive 400 IU vitamin D3 from routine antenatal multivitamin supplement tablet + 400 IU vitamin D3 daily until delivery.

Control

The control arm will receive 400 IU vitamin D3 per day from routine antenatal multivitamin supplementation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D3

The intervention arm will receive 400 IU vitamin D3 from routine antenatal multivitamin supplement tablet + 400 IU vitamin D3 daily until delivery.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Loy See Ling

Senior Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Loy See Ling, PhD

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

CIRB 2021/2055

Identifier Type: -

Identifier Source: org_study_id