NCT06054919

Brief Summary

This study is a randomized controlled trial which compares the effect of vitamin D3 therapy 5,000 IU daily and 50,000 IU on 25(OH)D and 1,25(OH)2D, VDBP, and 24,25(OH)2D maternal serum levels in pregnant women with vitamin D deficient and insufficient.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

2.7 years

First QC Date

September 5, 2023

Last Update Submit

September 22, 2023

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (4)

  • 25(OH)D maternal serum level

    quantified by direct competitive Chemilumiscence Immunoassay (CLIA) using LIAISON®.

    4 weeks after intervention

  • 1,25(OH)2D maternal serum level

    quantified by Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS) using ImmuTube®.

    4 weeks after intervention

  • VDBP maternal serum level

    quantified by Enzyme-Linked Immunosorbent Assay (ELISA) using Quantikine®

    4 weeks after intervention

  • 24,25(OH)2D maternal serum level

    quantified by Acquity I Class Binary Solvent Manager FTN , Xevo TQXS Tandem Mass Spectrometry (Waters Corporation)

    4 weeks after intervention

Study Arms (2)

50,000 IU

EXPERIMENTAL

Vitamin D3 50,000 IU weekly a standard prenatal multivitamin (fumarate Fe 90 mg; folic acid 0.4 mg; vitamin B6 3 mg; vitamin B12 5 mcg; sulphate cupric 0.35 mg, sulphate cobalt 0.15 mg, sulphate mangan 5 mcg, vitamin C 60 mg, vitamin E 5 mg, and phosphate calcium 60 mg)

Drug: Cholecalciferol

5,000 IU

ACTIVE COMPARATOR

Vitamin D3 5,000 IU daily a standard prenatal multivitamin (fumarate Fe 90 mg; folic acid 0.4 mg; vitamin B6 3 mg; vitamin B12 5 mcg; sulphate cupric 0.35 mg, sulphate cobalt 0.15 mg, sulphate mangan 5 mcg, vitamin C 60 mg, vitamin E 5 mg, and phosphate calcium 60 mg)

Drug: Cholecalciferol

Interventions

CholecalciferolDRUG

vitamin D3

Also known as: vitamin D
5,000 IU50,000 IU

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women with gestational age of ≤ 14 weeks
  • vitamin D deficient or insufficient (25(OH)D \<30 ng/ml\]
  • positive fetal heart rate from ultrasound examination.

You may not qualify if:

  • multiple pregnancy
  • pregnancy with congenital anomaly
  • hyperemesis gravidarum, diarrhea
  • complicated medical history (hypertension, diabetes mellitus, heart, kidney, or liver disease)
  • use of any dietary supplement containing vitamin D prior to enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo National Center General Hospital

Jakarta Pusat, DKI Jakarta, 13730, Indonesia

Location

Related Publications (1)

  • Syafitri I, Irwinda R, Saroyo YB, Purwosunu Y, Wibowo N. Maternal concentrations of vitamin D metabolites in response to high-dose oral vitamin D during first trimester pregnancy: a randomized controlled trial. BMC Nutr. 2025 Jul 4;11(1):117. doi: 10.1186/s40795-025-01104-3.

    PMID: 40616177DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Rima Irwinda, MD, PhD

    Departement of Obstetrics and Gynecology, Faculty of Medicine University of Indonesia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, OBGYN, PhD

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 26, 2023

Study Start

April 1, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings

Shared Documents
STUDY PROTOCOL
Time Frame
the data will become available in June 2024
Access Criteria
there is no access criteria

Locations

ID(1)