Effect of Maternal Vitamin D Supplementation During Pregnancy on Offspring Bone Mass, Body Composition and Muscle Strength in Early Childhood: Follow-up of a Randomized Controlled Trial Cohort.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 642
- 试验地点
- 1
- 主要终点
- Total-body-less head bone mineral content and total-body-less head bone mineral density
研究概览
简要总结
Vitamin D deficiency in childhood leads to poor bone growth and muscle weakness, yet it is unknown if the amount of vitamin D a woman consumes during her pregnancy affects her child's bone and muscle development. In collaboration with researchers in Bangladesh, the investigators recently completed a study of vitamin D supplementation during pregnancy in which women were assigned to 1 of 5 groups containing vitamin D or placebo (no vitamin D). The investigators now aim to conduct a follow-up study of a sample of 600 4 year old children born to these mothers to test the possible effects of vitamin D supplementation in pregnancy on children's bones, their body composition and the strength of their muscles.
详细描述
Vitamin D is a modifiable regulator of bone mineral metabolism and muscle function; yet little is known about the role of in utero vitamin D exposure on bone mineral accrual and muscle development in early childhood. Observational findings suggest associations between prenatal vitamin D status and infant bone, lean and fat mass and muscle function, but data from intervention trials is either unavailable or limited to early infancy. The investigators of the proposed study have previously shown that prenatal vitamin D supplementation safely improves maternal-fetal vitamin D status and perinatal calcium metabolism. Given the current interest in the potential role of vitamin D in perinatal health, adequately powered and well-designed randomized trials are required to investigate the effect of maternal vitamin D supplementation on offspring musculoskeletal health and body composition.
The investigators recently conducted the Maternal Vitamin D for Infant Growth (MDIG) trial (NCT01924013), a randomized placebo-controlled dose-ranging trial of vitamin D supplementation in pregnancy and lactation in Bangladesh, where severe vitamin D deficiency is common. Women at 17-24 weeks' gestation were randomized to 1 of 5 dose groups comprising a prenatal:postpartum regimen of placebo:placebo, 4200:0, 16800:0, 28000:0 or 28000:28000 IU vitamin D3/week until 26 weeks postpartum. Enrolment (n=1300) was completed in September 2015, and all infants were delivered by February 2016. The MDIG trial was primarily designed to determine the effect of maternal vitamin D on infant length at 12 months of age, with follow-up continuing until infants reached 24 months of age (completed in March 2018).
In the proposed observational follow-up study, the investigators will leverage the design and infrastructure of the MDIG trial to investigate effects of vitamin D on early childhood bone and muscle outcomes in a sample of MDIG participants at 4 years of age (target n=600 with 120 participants per maternal vitamin D treatment group; to allow for an expected attrition rate of 15%, the required sample size will be inflated to 140 children per group, giving an overall target sample size of 700 children).
The primary objective is to quantify the effects of prenatal vitamin D supplementation versus placebo on offspring total-body-less head (TBLH) bone mineral content and density. Secondary objectives are to examine the effect of vitamin D on TBLH lean and fat mass, and muscle function. Bone, lean and fat mass will be measured using dual-energy x-ray absorptiometry (DXA). Muscle strength (handgrip test), anthropometry, dietary intake and vitamin D status will also be assessed, in addition to biomarkers of bone turnover that may affect musculoskeletal health in young children.
The proposed follow-up study of a large randomized trial will contribute new evidence regarding the effects of vitamin D supplementation during pregnancy on musculoskeletal health in childhood.
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
- 45 Months 至 51 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The sample population will be drawn from a cohort registry of mother-infant pairs who participated in the recently-completed Maternal Vitamin D for Infant Growth (MDIG) randomized controlled trial (NCT01924013):
- •Child is available for participation at 45 to 51 months postnatal age
- •Mother received ≥80% of assigned prenatal vitamin D or placebo doses during the MDIG trial
- •Child and primary caregiver(s) reside in Dhaka, Bangladesh or nearby regions
- •A parent/guardian provides written or thumb-print informed consent for study procedures
排除标准
- •Mother participated in the MDIG trial but chose not to be included in the cohort registry for contact regarding follow-up studies
- •Children outside the eligible age range (aged below 45 months or above 51 months)
- •Child is diagnosed with any developmental disorder that would render difficulty in completion of the DXA scan (e.g. Autism)
- •Child is unable to bear weight on his/her legs (e.g. wheelchair bound)
- •Child has a current fracture or break in which his/her limb is supported by an orthopedic cast
结局指标
主要结局
Total-body-less head bone mineral content and total-body-less head bone mineral density
时间窗: 4 years of age
Measured by DXA
次要结局
- Whole-body (including head) bone mineral content and whole-body bone mineral density(4 years of age)
- Total-body-less head lean and total-body-less head fat mass(4 years of age)
- Head bone mineral content and head bone mineral density(4 years of age)
- Muscle function (handgrip strength)(4 years of age)
- Whole-body lean and whole-body fat mass(4 years of age)
研究者
Daniel Roth
Staff Physician
The Hospital for Sick Children