NCT04841265

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 28, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

1.9 years

First QC Date

April 6, 2021

Last Update Submit

July 4, 2024

Conditions

Overweight and Obesity

Keywords

Vitamin D supplementationLipid profileVitamin D statusBirth outcomesPregnancy complications

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Vitamin D3

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D3

Control

NO INTERVENTION

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

Interventions

Vitamin D3DIETARY_SUPPLEMENT

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

Vitamin D3

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOverweight and obese pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

OverweightObesityPregnancy Complications

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Dr Loy See Ling, PhD

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 12, 2021

Study Start

May 28, 2021

Primary Completion

April 11, 2023

Study Completion

March 31, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)