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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- 25(OH)D maternal serum level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Cholecalciferol (Drug)
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)
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
25(OH)D maternal serum level
时间窗: 4 weeks after intervention
quantified by direct competitive Chemilumiscence Immunoassay (CLIA) using LIAISON®.
1,25(OH)2D maternal serum level
时间窗: 4 weeks after intervention
quantified by Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS) using ImmuTube®.
VDBP maternal serum level
时间窗: 4 weeks after intervention
quantified by Enzyme-Linked Immunosorbent Assay (ELISA) using Quantikine®
24,25(OH)2D maternal serum level
时间窗: 4 weeks after intervention
quantified by Acquity I Class Binary Solvent Manager FTN , Xevo TQXS Tandem Mass Spectrometry (Waters Corporation)
次要结局
未报告次要终点
研究者
Rima Irwinda
MD, OBGYN, PhD
Indonesia University