Randomized trial of effect of micronutrient fortified biscuit on immunity status among school children
- Registration Number
- CTRI/2017/08/009368
- Lead Sponsor
- ITC Life Sciences and Technology Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 703
1. Willing to consume the test product for the entire duration of study.
2. Willing to participate in the study and perform all measurements including anthropometry, physical test, cognition test, dietary intake and questionnaires.
1. Children using medications (such as antiepileptic, anti TB drugs, steroids) which can affect the study outcome.
2. Children with Asthma and hypersensitivities.
3. Severely undernourished as defined by HAZ, WAZ or WHZ greater than â??3 SD from NCHS reference standard z-scores (Ogden et al, 2002)
4. Severely iron deficient as defined by haemoglobin concentrations <80 g/L (WHO, 2001)
5. Reported participation in another biomedical trial 3 months before the start of the study or during the study.
6. Reported dietary restrictions such as a medically prescribed diet during the study (Inborn errors of metabolism etc.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the effect of micronutrient fortified Nutritional Products in reducing the occurrence of infectious illness such as Respiratory and gastrointestinal tract and other infections in school children.Timepoint: Sept 15 2016 to December 28 2017
- Secondary Outcome Measures
Name Time Method Cognitive development <br/ ><br>Timepoint: 1 year;Improvement in growth <br/ ><br> <br/ ><br>Timepoint: 6 month and 1 year <br/ ><br> <br/ ><br>;Physical enduranceTimepoint: 1 year