A Randomized, Open-label, Cross-over Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Parental and infant preference for a new vitamin D delivery system over the standard of care supplement in syrup form.
研究概览
简要总结
Vitamin D supplementation (400 IU/d) is recommended for all breastfed infants in Canada. Such recommendation is grounded in the fact that the prevalence of rickets in Canada is higher than desirable, likely due to low maternal-fetal transfer and low intakes postpartum.
There is little data about adherence to supplementation in Canada, but one study shows that in primiparous mothers (n=1937) in Quebec, 58.1 % of those exclusively breast-feeding gave their infant vitamin D supplements in the first six months and 62.1 % of those feeding formula did not. For the Canadian situation, it is not clear if the modality of the supplementation is a barrier to providing the supplement. Thus the overall aim of this study is to test a new delivery system for parental preference and infant acceptance compared to a standard vitamin D supplement.
详细描述
OBJECTIVES
- To determine parental preference for a new vitamin D delivery system over the standard of care supplement in syrup form.
- To determine infant acceptance for a new vitamin D delivery system over the standard of care supplement in syrup form.
- To establish possible barriers to either supplement delivery system being given during infancy.
METHODOLOGY Design: randomized cross-over design, open label. Visit 1 (D1): written consent, demographic survey at first visit, randomize to order of supplement trial to begin with D Strip or syrup drops. obtain infant weight, complete health survey, instruct how to use supplement Call 1 (D4-D6): telephone call to address any questions or concerns, remind of next visit.
Visit 2 (on or around D21): complete survey instrument for first supplement, obtain infant weight, complete health survey, instruct how to use second supplement Call 2: (D25-27): telephone call to address any questions or concerns, remind of next visit.
Visit 3 (on or around D42): complete survey instruments, obtain infant weight; education regarding continued use of vitamin D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 2 Weeks 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy singleton newborn infants born at term age of any racial background.
- •Infants may be breastfed or formula fed during the study as is safe since the supplement is 400 IU/d and intakes from breast milk or formula will not exceed 400 IU/d for a theoretical total intake of 800 IU/d that is recommended by the Canadian Pediatric Society.
排除标准
- •Infants born prematurely, twins or other multiples.
- •Unable to nurse or accept the supplement.
- •Congenital malformations.
- •Parents not fluent enough in English or French to provide written informed consent.
结局指标
主要结局
Parental and infant preference for a new vitamin D delivery system over the standard of care supplement in syrup form.
时间窗: 21 days
次要结局
- Barriers to either supplement delivery system being given during infancy.(21 days)
研究者
Hope Weiler
Associate Professor
McGill University