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A randomized controlled trial on primary school children and mothers to assess the efficacy of a micronutrient fortified rice (iron, folic acid, vitamin B12) to improve iron stores

Long term (2 years) efficacy of indigenously developed micronutrient fortified rice (fortified with iron, vitamin B12 and folic acid) in improving iron stores in school children and their mothers; process standardization to match the physical characteristics of fortified rice kernels (FRK) with commercial rice varieties and storage stability.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018567
Enrollment
400
Registered
2019-04-12
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: Micronutrient fortified rice: Micronutrient fortified rice fortified with micronutrients (iron: 4.25mg/100g, vitamin B12:0.125 µg /100g, folic acid: 12.50 µg /100g). Intervention peri
25kg/month/household Control Intervention1: Rice: Non-fortified control rice which will be â??sona masuriâ?? variety natural rice grains.

Sponsors

Department of Biotechnology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Apparently healthy, rice eating family 2. Not severely malnourished weight-for-height z-score >=-2 not severely anemic (Hb 3. Age: 6-12 years for school children, mothers >18 years 4. Not taking any food supplements/fortified drinks 5. Not planning to move out during the study duration

Exclusion criteria

Exclusion criteria: 1. Age: 12 years 2. Severe anemia (mother and child, Hb 3. Severely malnourished children with weight-for-height z-score 4. Haemoglobinopathies, 5. Cardiovascular disease, respiratory disease, or any other chronic condition on clinical examination or history (mother/child) 6. Recent history (3 months prior) of serious infections, injuries and/ or surgeries 7. Any food allergy or food intolerance 8. Participation in any nutritional study in the last 1year 9. Children consuming nutritional supplements and/ or health food drinks 10. Likely to move out of the study area within the period of study intervention

Design outcomes

Primary

MeasureTime frame
â?¢To determine the efficacy of micronutrient fortified rice (containing micronized ferric pyrophosphate, vitamin B12 and folic acid) in improving iron stores in school children in Koppal district, Karnataka.Timepoint: 2 years—

Secondary

MeasureTime frame
â?¢ To determine the efficacy of MFR in: a)reducing the prevalence of iron deficiency among school children and their mothers in Koppal district, Karnataka b)in improving the micronutrient status (vitamin B12 and folic acid) in school children and their mothers (iron stores, vitamin B12 and folate levels) in Koppal district, Karnataka â?¢ To determine acceptability and long-term stability on storage of MFR at field conditions (1, 2, 3 months) during the efficacy study.Timepoint: 2 years—

Countries

India

Contacts

Public ContactDr Prashanth Thankachan

St Johns Research Institute

prashanth.t@sjri.res.in9886006166

Outcome results

None listed

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