A Randomized Controlled Trial to Investigate the Effects of Vitamin D supplementation on maternal and new-born baby’s vitamin D status in Asian-Indian Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Changes in vitamin D status of mother and newborn as measured by serum 25 hydroxy vitamin D level
研究概览
简要总结
In the proposed study, we are planning to investigate the efficacy of three doses of vitamin D supplementation on vitamin D status of mother and newborn at the time of delivery, in comparison to control group who will receive 600 IU per day. Subjects will be randomized into one of the four groups (three intervention groups and one control group), in the ratio of 1:1.
Subjects in intervention group will receive vitamin D (cholecalciferol) in increasing supplemental doses (Group 1 – 1000 units/day; Group 2 – 2000 units/day; Group 3 - 4000 units per day) while control group will receive 600 units of vitamin D per day. Although dose of supplementation has been calculated from daily dose basis, but it will be given, orally, once a month dose.
Dose of supplementation - Control group will receive 18,000 IU orally once a month while group 1 will receive 30,000 IU per month, group 2 will receive 60,000 IU per month while group 3 will receive 120,000 IU per month. All doses of vitamin D will be given as supervised dose in the hospital (supervised by study staff). Doses of vitamin D will be given till delivery.
In addition, all study subjects (intervention as well as control group) will also receive 1000 mg of elemental calcium (in two divided doses), similar nutritional and lifestyle advice as part of standard management of pregnancy. After 6-7 months of supplementation, all groups will be compared for primary and secondary outcomes of the study at the time of delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •â€¢Pregnant women between 12-16 weeks of gestation.
- •â€¢Age between 18 to 35 years.
- •â€¢Subjects agrees for delivery conducted at the AIIMS.
排除标准
- •Subjects will be excluded from the study if they •Have more than one gestation in current pregnancy •Complicated medical or obstetric history that may increase the risk of preterm birth or labor/ delivery complications, based on self-report or clinical assessment by obstetrician (cardiovascular disease, more than three abortions ,hypertension, preeclampsia or Rh isoimmunization) •Prior history of delivery of an infant with chromosomal abnormalities or IUGR in previous pregnancy •Presence of any diagnosed systemic disease known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism.
- •â€¢Have features suggestive of osteomalacia or severe VDD.
- •â€¢Pre-existing hypertension •Already diagnosed with diabetes (type 1 or 2) •Are taking or had taken vitamin D supplementation in last two months in doses exceeding 600 IU/day.
- •â€¢Are using medications known to interact with vitamin D metabolism (steroids,thiazide diuretics, phenytoin, phenobarbitone and antitubercular drugs).
- •â€¢Have known hypersensitivity to Vitamin D preparations.
- •â€¢Have participated in any other investigational drug study in previous three months.
- •â€¢Have past history of bariatric surgery.
- •â€¢Are using Ultra-Violet (UV) radiations as a part of medical therapy.
- •â€¢Are diagnosed with albinism or have other condition associated with decreased skin pigmentation.
- •â€¢Have any medical condition that in the judgment of the investigator would jeopardize the subject’s safety or evaluation of study drug for efficacy or safety .
- •Additional exclusion criteria will be applied after biochemical screening: •Having gestational diabetes between 12-16 weeks of pregnancy.
- •â€¢Have serum calcium more than 1 mg/dL above the upper limit of normal for age.
- •â€¢Have serum S.25(OH)D level more than 100 ng/mL.
结局指标
主要结局
Changes in vitamin D status of mother and newborn as measured by serum 25 hydroxy vitamin D level
时间窗: Mother: at start of study, 26-30 week and at the time of delivery; Newborn: cord blood
次要结局
- 1. Weight gain(2. pre-eclampsia)