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The Effect of Vitamin D3 Therapy on Vitamin D Status in Pregnant Women With Vitamin D Deficient and Insufficient

Sponsor
Indonesia University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06054919
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
32
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

This is a randomized controlled trial of vitamin D therapy of 5,000 IU daily or 50,000 IU weekly during pregnancy. The study is conducted at Cipto Mangunkusumo National Center General Hospital and Koja Distict Hospital in Jakarta, Indonesia from April 2021 - December 2023. All the pregnant women are screened for eligibility when they presented to the clinic for antenatal care visits and are offered enrolment if they meet the following inclusion criteria: gestational age of ≤ 14 weeks, vitamin D deficient or insufficient (25(OH)D <30 ng/ml], and positive fetal heart rate from ultrasound examination.

Participants are randomly assigned to one of two parallel intervention groups, with allocation concealment: vitamin D3 (cholecalciferol) 5,000 IU/week or 50,000 IU/week. All participants are given a standard prenatal multivitamin. A medical history, physical, and ultrasound examination are performed. Participants complete a questionnaire about sunlight exposure. Interventions in both groups are given for four weeks. Baseline blood tests, including serum 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D are performed at recruitment. After four weeks of interventions, the maternal venous blood is collected to assess serum 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D.

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Vitamin D3 Therapy on 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D Maternal Serum Levels in Pregnant Women With Vitamin D Deficient and Insufficient
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 50,000 IU

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
vitamin D3
Other Names:
  • vitamin D

    		•
    Active Comparator: 5,000 IU

    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
    vitamin D3
    Other Names:
  • vitamin D

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 25(OH)D maternal serum level [4 weeks after intervention]

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

    2. 1,25(OH)2D maternal serum level [4 weeks after intervention]

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

    3. VDBP maternal serum level [4 weeks after intervention]

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

    4. 24,25(OH)2D maternal serum level [4 weeks after intervention]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cipto Mangunkusumo National Center General Hospital Jakarta Pusat DKI Jakarta Indonesia 13730

    Sponsors and Collaborators

    • Indonesia University

    Investigators

    • Study Chair: Rima Irwinda, MD, PhD, Departement of Obstetrics and Gynecology, Faculty of Medicine University of Indonesia

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Rima Irwinda, MD, OBGYN, PhD, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT06054919
    Other Study ID Numbers:
    • 257/UN.2F1/ETIK/PPM.00.02/2023
    First Posted:
    Sep 26, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vitamin D Deficiency
    Vitamin D
    Cholecalciferol

    Study Results

    No Results Posted as of Sep 26, 2023