Skip to content

An efficacy trial to examine the effects of multiple micronutrient fortified rice for improving anemia, micronutrient status, growth, cognitive and physical performance in anemic school children in South India

Efficacy of multiple-micronutrient fortified rice for improving anemia, micronutrient status, growth, cognitive and physical performance in anemic school children in South India

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000941
Enrollment
258
Registered
2010-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Arm-1: 12.5mg Fe, 938 IU vit A, 0.38mg Vit B1, 5mg Vit B3, 0.38mg Vit B6, 0.008mg Vit B12, 0.008mg Folic acid, 3mg Zn Intervention2: ARM-2: 6.3mg Fe, 938 IU Vit A, 0.38mg Vit B1, 5mg Vi

Sponsors

St John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Primary school children registered into the selected school(s) - 6-12y mild-moderately anemic (Hb >90 g/L and <115 g/L for children aged 5-11 y; Hb > 90g/L and <120 g/L in children 12y).

Exclusion criteria

Exclusion criteria: - Taking micronutrient supplements - Have major medical conditions other than mild-moderate anemia - Severely anemic (Hb<90 g/L) - Severely malnourished (weight-for-height z-score <-3) - Girls who have started their menstruation prior to enrolment

Design outcomes

Primary

MeasureTime frame
The primary objective is to examine the effect of multiple-micronutrient fortified rice on hemoglobin level and anemia prevalence among mild-moderately anemic school children in Bangalore, India.The primary outcomes will be the change in haemoglobin concentration and prevalence of anemia.Timepoint: 28 weeks

Secondary

MeasureTime frame
The secondary objective is to determine whether the provision of multiple-micronutrient fortified rice will improve iron and other micronutrient (i.e., vitamin A, vitamin B, and zinc) status and reduce ID and IDA in school children. The impact of fortified rice on the physical growth and incidence of morbidity such as diarrhea will be assessed. In addition, it will be assessed whether the cognitive and physical performance of school children improves after consuming rice fortified with multiple-micronutrient 6 days a week for a period of 7 months.The secondary end point variables will be: 1) Biochemical outcomes (serum concentrations of ferritin, transferrin receptor, zinc protoporphyrin, retinol, zinc, homocysteine) - Serum ferritin (SF), transferrin receptor (TfR), zinc protoporphyrin (ZnPP) - SF or TfR + ZnPP: prevalence of iron deficiency - SF + Hb or TfR + ZPP + Hb: prevalence of iron deficiency anemia - Serum retinol (SR); Vitamin A deficiency - Serum zinc (SZn): zinc deficiency 2) Physical growth (body weight, height) - Body weight - Height 3) Physical performance, Cognitive development and performance - Short term memory - Reasoning ability - Language production - Visuo-spatial ability - Attention / concentration 5) Morbidity (frequency of morbidity with common illnesses) - Frequency of morbidity: e.g., high fever, diarrhea, absenteeism from school due to illness etc Timepoint: 28 weeks

Countries

India

Contacts

Public ContactDr.Prashanth Thankachan
praxmail@gmail.com+ 91 80 22065060

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026