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

University of Indonesia (UI)

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Vitamin D Deficiency

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT06054919

257/UN.2F1/ETIK/PPM.00.02/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

50,000 IU

Experimental group

Description:

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)

Treatment:

Drug: Cholecalciferol

5,000 IU

Active Comparator group

Description:

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)

Treatment:

Drug: Cholecalciferol