A study to reduce anemia in school going children with a low cost iron and vitamin c, tasty fizzy drink.

Completed

Conditions: Healthy Iron deficient Indian School children of the age group 07-11 years of both genders.

Registration Number: CTRI/2017/07/009131

Lead Sponsor: Jamsetji Tata Trust

Brief Summary: Iron deficiency (ID) and iron deficiency anemia (IDA) are globally considered as the most prevalent nutrient deficiency in the world. The sheer number of lives affected worldwide is shocking, It is estimated that 2 billion people worldwide are iron deficient including one billion who suffer from IDA(1). In India, 74% of the children below 5 years of age and 52% of young women have anemia (2). Poor dietary iron intake (3) and decreased iron absorption are the two main factors responsible for nutritional iron deficiency affecting poor populations (4). Plant based diets commonly consumed in

India and other developing countries have low iron content and also contain an abundance of phytates and polyphenols that inhibit the absorption of dietary non-heme iron (5), by forming insoluble complexes, thereby making it unavailable for absorption (6, 7). Rice is predominantly consumed and iron content of rice-based diets could be in the range of about 7mg/1000 Kcal. Data from an unpublished survey of primary school children in Karnataka, where the median iron intake was found to be about 10 mg/day. Assuming a generous bioavailability of 5% across all intakes, the median iron absorbed would be about 0.5 mg/day. Thus for a child with 1mg iron as the physiological requirement per day he/she will have a daily deficit of0.5 mg/day, or half the

childâ€™s requirement is only met. Over the days and years this deficit accrues and is further worsened by the increase in iron requirement around puberty.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 136

Inclusion Criteria

1.Aged 7-11 years 2.Low socioeconomic status 3.Serum Ferritin <30 Âµg/L.

Exclusion Criteria

1.Severe anemia (Hb<8g/dL) 2.Female with onset of menarche 3.Elevated serum CRP (>10 mg/L) 4.Need for any chronic prescription or over-the-counter medication 5.Intention to leave the school during the course of this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hb	Baseline and End line
serum transferrin receptor	Baseline and End line
Serum Ferritin	Baseline and End line
C - reactive protein	Baseline and End line

Secondary Outcome Measures

Name	Time	Method
height and weight	Baseline and End line

Trial Locations

Locations (1): St. Johns Research Institute
🇮🇳
Bangalore, KARNATAKA, India
St. Johns Research Institute
🇮🇳Bangalore, KARNATAKA, India
Dr Anura V Kurpad
Principal investigator
08049467000
a.kurpad@sjri.res.in