The Effect of Vitamin D3 Therapy on Vitamin D Status in Pregnant Women With Vitamin D Deficient and Insufficient
- Registration Number
- NCT06054919
- Lead Sponsor
- Indonesia University
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 52
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50,000 IU Cholecalciferol 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) 5,000 IU Cholecalciferol 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)
- Primary Outcome Measures
Name Time Method 25(OH)D maternal serum level 4 weeks after intervention quantified by direct competitive Chemilumiscence Immunoassay (CLIA) using LIAISON®.
1,25(OH)2D maternal serum level 4 weeks after intervention quantified by Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS) using ImmuTube®.
VDBP maternal serum level 4 weeks after intervention quantified by Enzyme-Linked Immunosorbent Assay (ELISA) using Quantikine®
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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cipto Mangunkusumo National Center General Hospital
🇮🇩Jakarta Pusat, DKI Jakarta, Indonesia