A study to check whether giving a special energy- and protein-rich food, along with normal home food, helps moderately undernourished children aged 6 months to 5 years gain weight better and stay healthy.

Efficacy, Safety and Tolerability of a Special feed EPDNS Energy Protein Dense Nutritious Supplement in Children with Moderate Acute Malnutrition. - EPDNS MAM Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/114182

Enrollment

250

Registered

2026-07-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: E440- Moderate protein-calorie malnutrition

Interventions

Intervention1: EPDNS: roasted groundnut, whole milk powder, sugar, coconut oil, vitamin-mineral premix

~542.81 kcal & 16.90 g protein/100 g 50 g/day for 6 23 months, 75 g/day for 24 59 months, orally in 2 3 divided feeds for 12 weeks, plus standard nutrition counselling + routine home food. Control I

Eligibility

Inclusion criteria

Inclusion criteria: Age 6 completed months to 59 months MAM defined as WHZ between minus 2 and minus 3 SD WHO standards OR MUAC more than 11.5 to less than 12.5 cm no bilateral pitting edema, clinically stable, good appetite passed appetite test parent guardian gives written consent and can attend 12 weeks of follow-up, not on any similar therapeutic or supplementary product.

Exclusion criteria

Exclusion criteria: SAM WHZ less than minus 3 SD, MUAC less than 11.5 cm, or bilateral pitting edema, acute illness needing urgent care or admission, poor appetite or failed appetite test, known allergy to groundnut, milk protein, coconut or premix, chronic systemic illness affecting growth or feeding CHD, CKD, CLD, malabsorption, cerebral palsy, malignancy, HIV, active or suspected TB, endocrine disorder, severe anaemia, on RUTF or RUSF or other nutrition programme, participation in another trial within 3 months, migration likely or cannot complete follow-up.

Design outcomes

Primary

Measure	Time frame
Mean weight gain g per kg from baseline to 12 weeks.Timepoint: Mean weight gain g per kg from baseline to 12 weeks.	—

Secondary

Measure	Time frame
Change in MUAC, change in WHZ, recovery from MAM, progression to SAM, adherence to EPDNS, palatability or acceptability, adverse events & SAEs, hospitalisation, dietary intake pattern 24-h recall, loss to follow-up.Timepoint: weeks 2, 4, 6, 8 and 12.	—

Countries

India

Contacts

Public ContactDr Neeta K Hatkar

Shri Bhausaheb Hire Government Medical College Dhule Maharashtra.

hatkardrneeta@gmail.com9823041819

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026