Impact evaluation of multi-micro-nutrient fortified rice in improving iron status among school childrenin rural district of Andhra Pradesh.
试验速览
- 阶段
- 不适用
- 状态
- Other
- 发起方
- Tata Trusts
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Compare the change in blood levels of SF,
研究概览
简要总结
Tata Trusts in collaboration with Andhra Pradesh State Civil Supplies Corporation Limited (APSCSCL) successfully piloted the usage of fortified rice in ICDS and Mid-day meals programs in West Godavari and Krishna districts. In this context, Tata Trusts has initiated an efficacy trial to capture the longitudinal impact of fortified rice on school children in Andhra Pradesh. In accordance with that, we have obtained necessary regulatory as well as ethical approvals and rolled out the efficacy study.
To this end, we have selected following Andhra Pradesh Social Welfare Residential (APSWR) Schools of Guntur and Prakasam Districts for the efficacy study.
· Adavithakellapadu (Boys School), Tadikonda (M), Guntur District- Treatment group
· Amaravati (Girls School), Amaravati (M), Guntur District- Treatment group
· Darsi (Boys School), Darsi (M), Prakasam District- Control group
· North Addanki (Girls School), Addanki (M), Prakasam District- Control group
Upon Selection of schools, we have initiated baseline assessment in all four schools during July 2019. As part of the assessment, we have conducted multiple medical camps and screened around 490 students and collected blood samples from students to track their CRP, HB levels as required by the study. Based on preliminary reports of baseline assessment, it was observed that around 160 students are suffering from Iron deficiency while 33% of students are anaemic.
After conducting the baseline assessment, with the support of Tata Trusts, APSCSCL has provided the fortified rice to treatment group students as per the study plan. In line with this, an intensive monitoring of the mechanism was kept in place to track the consumption patterns of the students during the study period.
As per study timelines, the end-line assessment was planned to conduct in April 2020. But After COVID-19 outbreak and nation-wide lockdown, it was decided to defer the study to April 2021 based on technical inputs from Government and study stakeholders.
However, due to the second wave of corona and the rapid spike in COVID-19 cases across the state, the Director of School Education, Andhra Pradesh has announced to classes 1 to 9th that all schools shall be closed under all managements with immediate effect (G.O. RT No. 11 dated 19.04.2021). Since our study population lies in the above group, it is not feasible to continue further owing to student unavailability to participate in the end line assessment.
In view of this and after detailed consultations with relevant stakeholders including technical partner- St Johns research institute, it was advised to dismiss the end line assessment study thereby entirely terminate the efficacy trial of rice fortification with immediate effect. The termination of the study will be informed to children and Management of respective schools as per study protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Children with iron deficiency and mild anaemia.
排除标准
- •Severe anaemia, prescription medication or supplement use; a history of serious illness, under acute medical care within the last 3 months, the presence of any other disease (reported), and food allergies.
结局指标
主要结局
Compare the change in blood levels of SF,
时间窗: Compare the change in blood levels of SF, | between the two groups at the end of the | intervention period
between the two groups at the end of the
时间窗: Compare the change in blood levels of SF, | between the two groups at the end of the | intervention period
intervention period
时间窗: Compare the change in blood levels of SF, | between the two groups at the end of the | intervention period
次要结局
- Compare change in prevalence of anaemia, iron(deficiency and iron deficiency anaemia between)
