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Randomized trial of effect of micronutrient fortified biscuit on immunity status among school children

Randomized Trial of effect of micronutrient fortified biscuit on immunity status among school children in Rural, Kolar. (Karnataka)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009368
Enrollment
700
Registered
2017-08-14
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 Nutritional product: Daily consumption - 25gms twice daily Control Intervention1: Placebo: Daily consumption - 25 gms twice daily

Sponsors

ITC Life Sciences and Technology Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 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.)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Cognitive development Timepoint: 1 year;Improvement in growth Timepoint: 6 month and 1 year ;Physical enduranceTimepoint: 1 year

Countries

India

Contacts

Public ContactDrMuninaryanaC

Sri Devaraj Urs Medical college

munispm@gmail.com

Outcome results

None listed

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