Department of Global Health and Population, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
Africa Academy for Public Health, Dar es Salaam, United Republic of Tanzania.
BMJ Open. 2023 Feb 15;13(2):e063686. doi: 10.1136/bmjopen-2022-063686.
Adolescence is a critical time for growth and development, but this age group is often neglected in research and development of nutrition interventions. Despite recommendations from the WHO to provide nutrient supplements to adolescents, evidence remains scarce on the most effective supplementation strategy. This study aims to compare weekly iron and folic acid (IFA) supplementation with daily multiple micronutrient supplements (MMSs) in prevention of anaemia and improvement of school outcomes among adolescents in Burkina Faso and Tanzania.
A three-arm cluster-randomised, school-based supplementation trial will be conducted among 84 schools (42 schools per site) and roughly 4500 students aged 10-17. Schools will be matched on three characteristics: number of students, school ranking profile, distance to main road (Tanzania) or distance to city council (Burkina Faso). Each school will be randomised to receive either weekly IFA, daily MMSs or serve as a control. Supplements will be delivered to students by teachers, who will provide monitoring data to the study team. Baseline and endline surveys will be conducted prior to and after each supplementation cycle (12 weeks in Burkina Faso; 1 year in Tanzania) to assess haemoglobin, anthropometry and sociodemographic variables. The primary outcome of haemoglobin will be analysed continuously using linear regression, and anaemia status will be analysed using logistic or multinomial regression, depending on categorisation level of the outcome. Secondary analyses of school performance indicators will also be conducted with either logistic or linear regression.
This protocol has been approved by the Institutional Review Board of the Harvard TH Chan School of Public Health (IRB20-1108) and the Research Ethics Committees for the Ministries of Health in Tanzania (Zanzibar) and Burkina Faso. Results will be disseminated during meetings with the Ministries of Health and the participating communities as well as through peer-reviewed publications.
NCT04657640; NCT05104554.
青春期是生长和发育的关键时期，但这一年龄组在营养干预措施的研究和开发中经常被忽视。尽管世界卫生组织建议向青少年提供营养补充剂，但关于最有效的补充策略的证据仍然很少。本研究旨在比较每周铁和叶酸（IFA）补充剂与每日多种微量营养素补充剂（MMS）在布基纳法索和坦桑尼亚预防青少年贫血和改善学校成绩方面的效果。
一项三臂整群随机、以学校为基础的补充试验将在 84 所学校（每个地点 42 所学校）和约 4500 名 10-17 岁的学生中进行。学校将根据三个特征进行匹配：学生人数、学校排名概况、距离主要道路（坦桑尼亚）或距离市议会（布基纳法索）的距离。每个学校将随机分配接受每周 IFA、每日 MMS 或作为对照。教师将向学生提供补充剂，他们将向研究小组提供监测数据。在每个补充周期（布基纳法索 12 周；坦桑尼亚 1 年）之前和之后进行基线和终点调查，以评估血红蛋白、人体测量学和社会人口统计学变量。血红蛋白的主要结果将使用线性回归连续分析，贫血状况将使用逻辑或多项逻辑回归分析，具体取决于结果的分类水平。还将使用逻辑或线性回归对学校表现指标进行二次分析。
本方案已获得哈佛 T.H.陈公共卫生学院机构审查委员会（IRB20-1108）和坦桑尼亚（桑给巴尔）以及布基纳法索卫生部研究伦理委员会的批准。结果将在与卫生部和参与社区的会议上以及通过同行评审出版物进行传播。
NCT04657640；NCT05104554。
