Novel Functional Outcomes of Vitamin D in Infancy; Can Correction of Low Vitamin D Status Program for a Leaner Body Composition Phenotype?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Lean mass
研究概览
简要总结
One in four infants are born with low amounts of vitamin D stored in their body. This study is designed to test whether improving vitamin D status quickly after birth helps infants to build muscle and to normalize growth. This is important since the investigators have noticed in previous work that infants with low vitamin D have higher body weight relative to body length later on and that those who develop very good stores quickly have a leaner body type. Therefore, in this study infants with low stores early after birth will be given either the regular amount of supplementation or a higher amount to more rapidly build up the vitamin stores in the body. Infants in both groups will be measured for muscle and fat mass at standardized ages during the first year of life and into the toddler years. The information will inform health care professionals and parents of the importance of establishing good vitamin D stores early in life. Vitamin D supplementation is a modifiable factor that is already recommended for all term born infants. Knowing how much is needed in infants born with low stores has not been tested in a controlled manner in Canada.
详细描述
Primary Trial Objective: To test whether rapid correction of vitamin D status early in the neonatal period results in greater lean mass in infancy.
It is hypothesized that neonates with low vitamin D status and provided a vitamin D supplement of 400 IU/d will have lower accretion of lean mass by 3 mo of age and thereafter by 12 months compared to infants given 1000 IU/d for the trial; and that this difference would be sustained up to 3 years after the trial at the post-trial follow-up phase.
Secondary Trial Objectives are designed a priori to test:
- Whether correction of low vitamin D status early in infancy using 1000 IU/d of vitamin D normalizes body composition (lean, fat, bone mass) and biomarkers across infancy; and for the follow-up (also referred to follow-on) study up to 3 y of age;
- Epigenetic mechanisms related to vitamin D metabolism and body composition that clarify how improving vitamin D status with 1000 IU/d of supplementation regulates the musculoskeletal system.
Tertiary Objective: outside of the trial, establish a healthy reference group with good neonatal vitamin D stores (>50 nmol/L 25(OH)D) and given 400 IU vitamin D/d with all of the same measurements as the trial since these are not all available (e.g. IGF-1, IGFBP3 using same assays).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 1 Week（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Appropriate weight for gestational age;
- •Infants born to mothers with otherwise healthy pregnancy and free of medications that impact vitamin D metabolism (except vitamin/mineral supplements) or fetal growth and intent to breastfeed to at least 3 months;
- •Infants born to mothers with gestational diabetes (screened for vitamin D status at birth and randomized to 400 or 1000 IU/d vitamin D under an ancillary arm of this study following the same protocol).
排除标准
- •Small for gestational age;
- •Maternal smoking in pregnancy, diabetes (types 1 or 2), preeclampsia, celiac disease, inflammatory bowel disease and medications that impact vitamin D/mineral metabolism.
结局指标
主要结局
Lean mass
时间窗: Trial phase is 1-12 months with primary end-point of 12 months. The follow-on study is up to 3 years.
Whole body lean mass
次要结局
- 25(OH)D, body composition (lean, fat, bone), bone density, biomarkers of vitamin D status, growth and bone.(Trial phase 1-12 months; follow-on study up to 3 years)
研究者
Hope Weiler
Associate Professor at time of the study launch.
McGill University