Completed

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

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What is being tested

Vitamin D3

Dietary Supplement
Who is being recruted

Urogenital Diseases+8

+ Body Weight

+ Female Urogenital Diseases and Pregnancy Complications

From 21 to 45 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: May 2021
See protocol details

Summary

Principal SponsorKK Women's and Children's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 28, 2021

Actual date on which the first participant was enrolled.

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 TitleThe Effect of Vitamin D Supplementation in Overweight and Obese Pregnant Women
NCT04841265
Principal SponsorKK Women's and Children's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

274 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 21 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesBody WeightFemale Urogenital Diseases and Pregnancy ComplicationsNutrition DisordersNutritional and Metabolic DiseasesObesityPregnancy ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

4 inclusion criteria required to participate
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

6 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

KK Women's and Children's Hospital

Singapore, SingaporeOpen KK Women's and Children's Hospital in Google Maps
CompletedOne Study Center