Newly Formulated, Extruded Fortified-blended Foods for Food Aid: the MFFAPP Tanzania Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,179
- 主要终点
- Hemoglobin Change
研究概览
简要总结
Corn-soy vitamin and mineral fortified blended foods (FBFs) are primarily used for food aid, although sorghum and cowpea may be suitable alternative FBF commodities. The objective of the Micronutrient Fortified Food Aid Pilot Project (MFFAPP) Tanzania Efficacy Study is to determine whether newly formulated, extruded sorghum- and cowpea-based FBFs have equal, or better, nutritive value and acceptance compared to a traditional corn-soy blend. The effectiveness of each blend will be determined in an efficacy study of Tanzanian children under the age of 5 that are deficient, or at risk for deficiency, in iron and vitamin A.
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
- 6 Months 至 53 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemoglobin <10.3mg/dl
- •Weight-for-height z-scores >-3
排除标准
- •Exclusive breastfeeding
- •Unwillingness to travel to health facilities
- •Enrollment of child in school during study period
- •Anticipated relocation of the family during the study
- •Allergy to the fortified-blended food product ingredients
研究组 & 干预措施
Control (No FBF)
FBF provided after the intervention period
Corn Soy Blend Plus (CSB+)
Consumed Corn Soy Blend Plus (CSB+)
干预措施: Corn Soy Blend Plus (CSB+) (Other)
Corn Soy Blend 14 (CSB14)
Consumed Corn Soy Blend 14 (CSB14)
干预措施: Corn Soy Blend 14 (CSB14) (Other)
White Sorghum Cowpea Blend Variety 1
Consumed White Sorghum Cowpea Blend Variety 1
干预措施: White Sorghum Cowpea Blend Variety 1 (Other)
White Sorghum Cowpea Blend Variety 2
Consumed White Sorghum Cowpea Blend Variety 2
干预措施: White Sorghum Cowpea Blend Variety 2 (Other)
Red Sorghum Cowpea Blend
Consumed Red Sorghum Cowpea Blend
干预措施: Red Sorghum Cowpea Blend (Other)
White Sorghum Soy Blend
Consumed White Sorghum Soy Blend
干预措施: White Sorghum Soy Blend (Other)
结局指标
主要结局
Hemoglobin Change
时间窗: 0, 10, 20 weeks (baseline, midline, and end line)
Dried blood spot retinol binding protein change
时间窗: 0, 10, 20 weeks (baseline, midline, and end line)
Assessment of vitamin A status
次要结局
- Weight-for-age change(0, 10, 20 weeks (baseline, midline, and end line))
- Weight-for-height change(0, 10, 20 weeks (baseline, midline, and end line))
- Moderate malnutrition status change(0, 10, 20 weeks (baseline, midline, and end line))
- Mid-upper arm circumference change(0, 10, 20 weeks (baseline, midline, and end line))
- Height-for-age change(0, 10, 20 weeks (baseline, midline, and end line))
研究者
Brian Lindshield
Associate Professor
Kansas State University