Effect of a Fortified Milk on Growth and Micronutrient Status in Mexican Toddlers. A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Change head circumference of anthropometrics from baseline at 4 months
研究概览
简要总结
The objective of the present study was to assess the effect of a growing-up milk on growth and micronutrient status in children 12 to 30 months of age.
The study was conducted in Cuernavaca, the state capital of Morelos, Mexico. The investigators included children who attended day-care centers. These day- care centers are part of a national government program which main objective is to support working mothers and those who intend to work and do not have access to a health service and are at risk of poverty. The study described herein is a randomized, parallel, double-blind, controlled trial by administration of growing up milk (GM) and fortified milk (FM).
Results showed a significant improvement in linear growth in both supplemented groups, with no statistical difference between treatments. By using an artificial, population-based comparison group, the investigators conclude that this improvement was attributable to the supplements.
详细描述
The study was conducted in Mexico. The investigators included children 12 to 30 months of age who attended day-care centers. These day- care centers are part of a national government program which main objective is to support working mothers and those who intend to work and do not have access to a health service and are at risk of poverty. The program also includes single parents in charge of their family with children between 12 and 36 months of age.
The study described herein is a randomized, parallel,double-blind, controlled trial by administration of growing up milk (GM) and fortified milk (FM).
Randomization and masking:
The Moses-Oakford method was used to randomly assign 189 children to 1 of 2 groups in this double-blind controlled trial by the administration of growth milk (Enfa-Grow® GM) (GM) and fortified milk (FM). There were 96 children in the red-gray group and 93 in the blue-green group, the study will be blinded until the statistical analysis is finished. One group received GM and the other group receive FM. Both groups received 480 mL/d (240 mL at 7:00 a.m. and 240 mL at 16:00 p.m.). Both supplements were indistinguishable, same color, (white milk powder) odor, and flavor except for the color-coding of the can. The color code was unknown for researchers, field workers, users and analysts. Milk was offered to the children 5d/wk for a period of 4mo under supervision of the study personnel who recorded whether the supplement was consumed as well as the amount.
Exclusion Criteria:
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
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who attended day-care centers
- •Children whose parents accepted to participate in the study.
排除标准
- •Children who were breastfed at the time of the study
- •Children receiving multiple micronutrient supplementation
- •Children with capillary hemoglobin <9.0g/dl, at baseline
- •Children clinically sick
研究组 & 干预措施
Growing Milk
Experimental Fortified milk has energy from fatty acids, protein and carbohydrates. This milk has probiotics and essential micronutrients such as Zn, Fe, vitamins ( A, D, E, K, C and B complex), selenium and Copper among others.
Intervention Milk powder was prepared and reconstituted every weekday at each day-care center according to WHO and Day Care guidelines. Bottles were used to facilitate measuring in milliliters and were weighted before and after preparing milk in a diet measuring scale. Mothers were given the amount of milk necessary to prepare 480 ml per day during the weekend.
干预措施: Growing milk (Dietary Supplement)
Fortified Milk
Fortified milk has no energy from fatty acids nor micronutrients such as vitamin B12, Selenium and Copper. This milk was prepared and reconstituted every weekday at each day-care center according to WHO and Day Care guidelines. Bottles were used to facilitate measuring in milliliters and were weighted before and after preparing milk in a diet measuring scale. Mothers were given the amount of milk necessary to prepare 480 ml per day during the weekend.
干预措施: Fortified milk (Dietary Supplement)
结局指标
主要结局
Change head circumference of anthropometrics from baseline at 4 months
时间窗: 4 months
Head circumference was taken at baseline and 16wks and transformed to Z scores by using the 2006 World Health Organization (WHO) reference standards.
Change in weight from baseline at 4 months
时间窗: 4 months
Weight was taken at baseline and 16wks and transformed to Z scores by using the 2006 World Health Organization (WHO) reference standards.
Change in length of anthropometrics from baseline at 4 months
时间窗: 4 months
Length was taken at baseline and 16wks and transformed to Z scores by using the 2006 World Health Organization (WHO) reference standards.
次要结局
- Change in Vitamin A(4 months)
- Change in Ferritin(4 months)
- Change in Folate(4 months)
- Change in DHA(4 months)
- Change in EPA(4 months)
- Change in Arachidonic acid(4 months)
- Change in Oleic acid(4 months)
- Change in Linoleic acid(4 months)
- Change in Palmitic acid(4 months)
- Change in Vitamin D(4 months)
- Change in Zinc(4 months)
研究者
Mario Flores-Aldana
Medical Sciences Reasercher
Instituto Nacional de Salud Publica, Mexico