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.

Iron-deficiency anaemia (IDA) and Iron deficiency (ID) are common among children and young women in India. Data from the National family health survey-4 show the prevalence of IDA to be high at >50% among school children and pregnant women. IDA has adverse health effects on infant growth, cognitive performance, pregnancy outcome, immune status and work capacity. Fortification of food with iron (Fe) can be an effective and sustainable approach to combating ID and IDA. The food vehicles that are most commonly fortified with micronutrients are cereals, as they account for a major proportion of the calorie and protein intake in diets of poor populations. Rice is the leading staple food in the developing world, where 95% of the world production of rice is harvested and approximately 90% is consumed (FAO, 2003). In Southern India, rice provides approximately 50% of total energy intake (FAO, 1998). Rice can be fortified by using extrusion technology, wherein the rice flour is mixed with appropriate levels of micronutrients and then re-shaped and cut in an extruder to obtain fortified rice grains premix. This technology has been used to produce rice grains fortified with iron and then blended with natural rice grains to obtain an adequate level of iron when consumed. In an earlier study conducted by us, extruded rice grains fortified with micronized ground ferric pyrophosphate (MGFP) was successfully tested in school children in Bangalore and found to have excellent sensory characteristics. When fed in a daily lunch meal over 7 months, it increased body iron stores and reduced the prevalence of iron deficiency in Indian children (Moretti, 2006). While this was a positive step toward controlling iron deficiency in these regions and did generate much needed scientific evidence of this approach on reducing the ID and IDA. The fortified rice that was evaluated earlier was manufactured at ETH, Zurich and no technology existed then that could manufacture the same in India. As large amounts of fortified rice would be required if one were to implement an intervention program in the rice eating states of India, a need for developing indigenous technology that manufactured extruded iron fortified rice was felt. Subsequently, Indian Institute of Technology Kharagpur developed technology and pilot scale unit for manufacturing iron fortified rice kernels (FRK) through extrusion.  The FRK is mixed with the normal rice in proportion of 1:99 to produce fortified rice with iron levels of 4.25mg/100g.  In this study, we plan to test the efficacy of this indigenously developed fortified rice among school children and their mothers in Koppal district of Karnataka, India, an area where ID and IDA is common and rice is the staple food. Similar to our earlier study we will use a randomized controlled trial design and assess the long term (two years) efficacy of the indigenously made fortified rice in improving iron status and reducing iron deficiency. The rice would be provided to the household (25 kg) every month and the mother would cook as she would normally do. The study children will consume two meals a day at home during school days and three meals at home on holidays and weekends. The mothers would consume all meals cooked at home. Weekly adverse events and history of any morbidity will be collected and ascertained over the study duration. The efficacy of the fortified rice will be evaluated in a two year, controlled, double-blind intervention trial in 6-11-year-old children with Fe deficiency and their mother. Selected children and their respective families will be randomized into two groups: a control group and an intervention group. The families of the children randomized into the control group will be provided with the monthly requirement of normal rice (NR) to cook and consume as is normally done and the families of the children randomized to the intervention group will receive the monthly requirement of micronutrient fortified rice to cook and consume as is normally done. The raw rice requirement for each family will be provided as monthly rations for 24 months. At baseline, weight and height will be measured and blood biochemistry for determination of haemoglobin, serum ferritin, C-reactive protein, AGP, soluble transferrin receptor, vitamin b12 and folic acid will be done. At the end of one and two years, the baseline measurements will be repeated to evaluate the efficacy of the micronutrient fortified rice in both selected children and their mothers.

Additionally, local acceptability to the fortified rice will be evaluated in a sub sample of the mothers of the school children. The fortified rice will also be stored in local conditions for 1-3 months during the efficacy study, to confirm colour stability.  Segregation of the FRK within MFR bags will also be evaluated prior to the start of the study using simulated transportation conditions and on storage at the household during the course of the study.