Randomized, Double-blind, Community-based Efficacy Trial of Various Doses of Zinc in Micronutrient Powders or Tablets in Young, Bangladeshi Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,886
- 试验地点
- 1
- 主要终点
- Incidence of diarrhea
研究概览
简要总结
This is a randomized, double-blind, community-based efficacy trial of different doses, forms, and frequencies of zinc supplementation for the prevention of diarrhea and promotion of linear growth among children 9-11 months of age in Dhaka, Bangladesh.
详细描述
Zinc is essential to support growth in young children especially for tissues undergoing rapid cellular differentiation and turnover, such as those in the immune system and gastrointestinal tract. Therapeutic zinc supplementation has been initiated in low-income countries as part of diarrhea treatment programs to support these needs for young children but, the effects of preventive supplemental zinc as a tablet or as a multiple micronutrient powder (MNP) on child growth and diarrheal disease are mixed and pose programmatic uncertainties. Thus, a randomized, double-blind community-based efficacy trial of five different doses, forms, and frequencies of preventive zinc supplementation vs. a placebo was designed for a study in children aged 9-11 months in an urban community in Dhaka, Bangladesh. The primary outcomes of this 24-week study are incidence of diarrheal disease and linear growth. Study workers will conduct in-home morbidity checks twice weekly; anthropometry will be measured at baseline, 12 weeks and 24 weeks. Serum zinc and other related biomarkers will be measured in a subsample along with an estimate of the exchangeable zinc pool size using stable isotope techniques in a subgroup. Therapeutic zinc will be provided as part of diarrhea treatment, in accordance with Bangladesh's national policy. Therefore, the proposed study will determine the additional benefit of a preventive zinc supplementation intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Months 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •9-11 months of age
- •Weight-for-length Z score >= -3 according to the 2006 World Health Organization Growth Standards
- •Hemoglobin concentration > = 7.0 g/dL
排除标准
- •Presence of severe acute malnutrition, defined as a WLZ <-3 and/or the presence of bipedal edema and/or mid-upper arm circumference <115 mm;
- •Presence of severe anemia, defined as a hemoglobin concentration < 7.0 g/dL
- •Congenital anomalies (e.g. cardiac defects, cleft lip or palate) or any other conditions that interfere with feeding;
- •Chromosomal anomalies and other organic problems (e.g. jaundice, tuberculosis)
- •Currently consuming MNPs with no intention of stopping
结局指标
主要结局
Incidence of diarrhea
时间窗: Incidence over the 24-week follow-up period
Incidence of diarrhea is defined as the number of diarrheal episodes per person-weeks of follow-up
Change in length-for-age Z score
时间窗: Measured at enrollment and the end of the 24-week follow-up period
Change in length-for-age Z score from enrollment to the end of the 24-week follow-up period
次要结局
- Change in stunting prevalence(Measured at enrollment and the end of the 24-week follow-up period)
- Change in the prevalence of zinc deficiency(Measured at enrollment and at the end of the 24-week follow-up period in subgroup of participants in all 6 intervention groups)
- Change in wasting prevalence(Measured at enrollment and at the end of the 24-week follow-up period)
- Incidence of diarrhea with dehydration(Measured twice weekly for 24 weeks)
- Incidence of hospitalizations(Assessed twice weekly for 24 weeks)
- Change in the exchangeable zinc pool size(Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.)
- Change in ferritin concentrations(Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants in all 6 intervention groups)
- Change in genome wide gene expression by RNA-sequencing(Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.)
- Change in cellular immune function by leukocyte profiles(Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.)
- Incidence of dysentery(Measured twice weekly for 24 weeks)
- Change in mean serum zinc concentration(Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants in all 6 intervention groups)
- Change in concentrations of soluble transferrin receptor(Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants in all 6 intervention groups)
- Change in gut microbiota(Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.)
- Change in amino acid metabolites associated with gut permeability(Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.)
- Change in specific gene expression by quantitative Polymerase Chain Reaction(Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.)
- Change in lipid metabolites associated with gut permeability(Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.)
- Change in serum cytokines(Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.)