Randomized Placebo-controlled Trial of Maternal Vitamin D Supplementation During Pregnancy and Lactation to Improve Infant Linear Growth in Dhaka, Bangladesh.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Infant Length-for-Age Z-Scores with Prenatal Supplementation
研究概览
简要总结
The primary aims of this study are: 1) to determine whether maternal prenatal vitamin D3 supplementation (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) versus placebo increases or decreases infant length at 1 year of age, and 2) to determine whether maternal postpartum vitamin D3 supplementation (28,000 IU/week) versus placebo increases or decreases length at 1 year of age among infants born to women who received vitamin D 28,000 U/week during pregnancy. Infants enrolled in the study will be followed for 2 years to document the persistence of any observed effects measured at 1 year of age. This study aims to enroll 1300 pregnant women in the 2nd trimester at a maternity hospital in Dhaka. Participants will be randomized to one of three doses of vitamin D3 (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) or placebo throughout pregnancy. Women in the 28,000 IU/week group will be additionally randomized to either placebo or a continuation of 28,000 IU/week for 6 months postpartum. In addition to linear length, the trial will include analyses of inflammatory and hormonal determinants of infant growth, epigenetic phenomena that affect vitamin D metabolism, and diarrheal and respiratory morbidity in the infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 years and above.
- •Gestational age of 17 to 24 completed weeks estimated based on recalled last menstrual period (LMP) and/or ultrasound.
- •Intends to permanently reside in the trial catchment area for at least 18 months.
排除标准
- •History of medical conditions that may predispose the participant to vitamin D sensitivity, altered vitamin D metabolism and/or hypercalcemia, or history of renal calculi.
- •High-risk pregnancy based on one or more of the following findings by point-of-care testing:
- •Severe anemia: hemoglobin <70 g/L assessed by Hemocue
- •Moderate-severe proteinuria: ≥ 300 mg/dl (3+ or 4+) based on urine dipstick
- •Hypertension: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg
- •Multiple gestation, major congenital anomaly, or severe oligohydramnios based on maternal history and/or ultrasound.
- •Unwillingness to stop taking non-study vitamin D or calcium supplements or a multivitamin with calcium and/or vitamin D.
- •Currently prescribed vitamin D supplements as part of a physician's treatment plan for vitamin D deficiency.
- •Previous participation in the same study.
研究组 & 干预措施
Group A
Prenatal Period 0 IU; Postpartum Period 0 IU (placebo)
Overall:The Prenatal Period will start at enrolment (17-24 weeks gestation) and last until delivery. The Postpartum Period will last from delivery until 6 months postpartum.
干预措施: Placebo (Dietary Supplement)
Group B
Prenatal Period 4,200 IU/week of vitamin D3 (=600 IU/d); Postpartum Period 0 IU/week (placebo)
干预措施: Vitamin D3 (cholecalciferol) (Dietary Supplement)
Group B
Prenatal Period 4,200 IU/week of vitamin D3 (=600 IU/d); Postpartum Period 0 IU/week (placebo)
干预措施: Placebo (Dietary Supplement)
Group C
Prenatal Period 16,800 IU/week of vitamin D3 (=2,400 IU/d); Postpartum Period 0 IU/week (placebo)
干预措施: Vitamin D3 (cholecalciferol) (Dietary Supplement)
Group C
Prenatal Period 16,800 IU/week of vitamin D3 (=2,400 IU/d); Postpartum Period 0 IU/week (placebo)
干预措施: Placebo (Dietary Supplement)
Group D
Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 0 IU/week (placebo)
干预措施: Vitamin D3 (cholecalciferol) (Dietary Supplement)
Group D
Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 0 IU/week (placebo)
干预措施: Placebo (Dietary Supplement)
Group E
Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 28,000 IU/week(=4,000 IU/d)
干预措施: Vitamin D3 (cholecalciferol) (Dietary Supplement)
结局指标
主要结局
Infant Length-for-Age Z-Scores with Prenatal Supplementation
时间窗: 1 year of age
Infant Length-for-Age Z-Scores with Postpartum Supplementation
时间窗: 1 year of age
A separate analysis will be performed to assess the effect of continuation of 28,000 IU/week postpartum supplementation versus placebo (postpartum) among participants randomized to 28,000 IU/week prenatal.
次要结局
- Serum calcium(17 weeks gestation to birth (prenatal) and over 2 years postpartum)
研究者
Daniel Roth
Staff Physician
The Hospital for Sick Children