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

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06054919
• Other study ID #: 257/UN.2F1/ETIK/PPM.00.02/2023
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
vitamin D3

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Center General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25(OH)D maternal serum level	quantified by direct competitive Chemilumiscence Immunoassay (CLIA) using LIAISON®.	4 weeks after intervention
Primary	1,25(OH)2D maternal serum level	quantified by Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS) using ImmuTube®.	4 weeks after intervention
Primary	VDBP maternal serum level	quantified by Enzyme-Linked Immunosorbent Assay (ELISA) using Quantikine®	4 weeks after intervention
Primary	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