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Development of a Millet-Based Complementary Food for Moderately Acute Malnourished Children.

Development of Fortified Ready to eat (RTE) Sanwa (Echinochloa frumentacea Roxb.) based complementary food and evaluation of its efficacy on Moderate Acute Malnourished (MAM) children aged 6-24 months: An Open-Label Double Arm Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084943
Enrollment
116
Registered
2025-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E41- Nutritional marasmus

Interventions

None listed

Sponsors

All India Institute Of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Full term (gestational age equal or over 37 weeks. Age 6-24 months. Diagnosed with moderate acute malnutrition based on WHO criteria. Able to consume study food. No known food allergy. Feeding by mouth with human milk or formula/ top feed.

Exclusion criteria

Exclusion criteria: Pre-term or small-for-gestational-age infants Children suffering from severe acute malnutrition. Infants having conditions that would affect normal growth; Not willing to feed the complementary food provided; - Antibiotics exposure during delivery or from birth to 5 months of life; multiple births. - Presence of any comorbidity including prematurity. - The children with congenital anomalies and infectious diseases such as upper/lower respiratory tract illness, urinary tract infections, and unable to swallow complementary foods. - Children suffering from any systemic illness. - Parents not willing to participate in the study

Design outcomes

Primary

MeasureTime frame
Improvement in anthropometric indices (weight, length/height, Mid upper arm circumference, chest circumference) as Per IAP. Improvement in weight for height z score. Timepoint: Improvement in anthropometric indices (weight, length/height, Mid upper arm circumference, chest circumference) as Per IAP.(assessment on 0th day 6th week- 12th week) Improvement in weight for height z score.(assessment on 0th day 6th week- 12th week)

Secondary

MeasureTime frame
Changes in Hb levels Acceptability and adherence to the porridge Timepoint: Changes in Hb levels (on 0th day - 6th week) Acceptability and adherence to the porridge (on 0th day - 6th week)

Countries

India

Contacts

Public ContactDr Rajagopala S

All India institute of Ayurveda, New Delhi

ayuarun@gmail.com8506821947

Outcome results

None listed

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