Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- weight gain (gram/day)
研究概览
简要总结
The study is designed to show equivalence of an infant formula containing L-5- Methyltetrahydrofolate (MTHF) compared to a standard infant formula containing folic acid in respect to weight gain of healthy term infants receiving these infant formulae exclusively during the first 4 months of life. Healthy non breast fed infants will be randomized to receive either a standard infant formula with folic acid or a corresponding formula with MTHF instead of folic acid. Besides weight and length further anthropometric measures will be taken monthly from the age of 4 weeks to the age of 16 weeks and at the age 4 and 16 weeks blood samples will be taken for the determination of folate status and genotyping. As a reference the same measures will be taken in a group of breast fed infants, whose mothers' folate status will be determined as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 27 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent (by parents, caregiver)
- •Healthy male or female infants <28 days of life
- •Gestational age at delivery ≥37 and ≤42 weeks
- •Birth weight between 2500 - 4500g
- •Parents / Caregivers are able to speak Serbian language
排除标准
- •Serious acquired or congenital diseases that is expected to interfere with normal feeding or growth
- •Feeding of more than 10% of energy (1 bottle/day) from sources other than the formula (or breast milk in the reference group) at inclusion
- •Participation in another clinical study
- •Mothers with diabetes mellitus (including gestational diabetes)
- •Reason to presume that the parents are unable to meet the study plan requirements
- •Diseases of the mother which have an effect on the child's gastro-intestinal tract/ability to be fed
- •Major abnormalities in hematological parameters
- •Major abnormalities in hepatic, renal or metabolic functions
- •Use of medication and vitamin supplements except vitamin K or D supplementation or vaccination
- •Mother follows a vegan diet
研究组 & 干预措施
infant formula containing folic acid
Infant formula including folic acid within the range stipulated by European legislation on infant formula
干预措施: infant formula containing folic acid (Other)
infant formula containing MTHF
Infant formula including MTHF instead of folic acid
干预措施: infant formula containing MTHF (Other)
Breast milk
non randomized reference group
结局指标
主要结局
weight gain (gram/day)
时间窗: age of 4 weeks until age of 16 weeks
次要结局
- dietary intake of study formula, non-study formula, additional liquids and solids(during the period age 4 weeks to age 16 weeks)
- feeding related behavior questionnaire(during the period age 4 weeks to age 16 weeks)
- body length gain (cm/day)(age of 4 weeks until age of 16 weeks)
- fronto-occipital head circumference gain (in cm/day)(at age of 4 weeks and at the age of 16 weeks)
- stool characteristics (color and consistency)(during the period age 4 weeks to age 16 weeks)