Vitamin B12 Status in Infancy and the Effect of Providing Vitamin B12 to Infants With Signs of Suboptimal Vitamin B12 Status - a Registry-based, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Prevalence of vitamin B12 deficiency
研究概览
简要总结
Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. Poor status is also seen in affluent countries such as in Norway. Vitamin B12 is crucial for normal cell division and differentiation and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation infants on neurodevelopment. We also aim to measure the impact of B12 supplementation on several other outcomes.
Study design: Individually randomized double-blind placebo-controlled trial breastfed infants who will be assigned to a screening group (in which measurements will be obtained immediately) or a control group (in which serum will be stored and measurements done after one year).
Pregnant women will be informed about the study during their first antenatal visit at the clinic and that we will re-approach them on their 6-week visit to their public health nurse. Infants who are deficient will be treated with peroral or intramuscular injections with 400 µg cyano-cobalamin.
Infants in the control group will not be offered any intervention their blood sample will be stored for one year and then analyzed for the same nutrients as the intervention group.
Outcomes: Primary: (i) neurodevelopment in children measured at 12 months of age (ii) growth in children measured by attained weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children later in life
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
- None
入排标准
- 年龄范围
- 1 Month 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Availability of informed verbal consent
- •Plan to reside in the defined study area for the next 12 months
- •Mothers intend to breastfeed their children for at least 8 months, and exclusively for 4 months
排除标准
- •Severe systemic illness requiring hospitalization
- •Growth retardation
- •Severe congenital malformations
- •Plasma cobalamin concentration <148 pmol/L (These children will be treated for vitamin B12 deficiency and not included in the RCT, but will be included in the cohort design)
结局指标
主要结局
Prevalence of vitamin B12 deficiency
时间窗: 1-3 months of age
Number of children with elevated plasma homocysteine or low cobalamin
Prevalence of other vitamin deficiencies
时间窗: 1-3 months of age
Number of infants with vitamin deficiencies other than vitamin B12 deficiency
Neurodevelopment
时间窗: 12 months of age
Bayley Scales of Infant Development 4th edition
次要结局
- Neurodevelopment measured by the Ages and Stages Questionaire(4-12 months of age)
- Vagal tone(12 months of age)
- Eye tracking(12 months of age)
- Neurodevelopment later in childhood(5 years)
- Adverse events(3 months after treatment with vitamin B12)