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Clinical trial on children with mild to moderate acute malnutrition in India

Impact of Indigenously prepared Nutritional supplement in children with mild to moderate acute malnutrition in India- a facility-based study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050435
Enrollment
300
Registered
2023-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: E46- Unspecified protein-calorie malnutrition

Interventions

Intervention1: Nutritional supplement: 10 gms in the morning with water for 90 days Control Intervention1: Milk: 150 ml milk once in the morning for 90 days

Sponsors

Netsurf Communications Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children in between 2 to 6 years of either sex.2.Guardian/ parent is willing to provide consent and follow the schedule of the study.3.Patient evaluated with Grade 1 and Grade 2 of Malnutrition (I.A.P Grading of Malnutrition)4.Patients with PEM

Exclusion criteria

Exclusion criteria: 1.Children who have Systemic diseases like Tuberculosis, Diabetes, any other grave infectious illness requiring active management. 2.PEM due to Gross congenital problems, Malignancies, Mal-absorption syndrome or inborn errors of metabolism will be excluded. 3.Children evaluated with other grades of PEM, i.e. normal, grade 3 4.and grade 4 as per IAP classification

Design outcomes

Primary

MeasureTime frame
1.Growth- Change in weight and height (WHO z-score) at screening and day 90.Timepoint: Screening Visit, Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90)

Secondary

MeasureTime frame
1.Changes in hematological parameters from screening to day 90. 2.Immunity profile - No. of recurrent acute upper respiratory tract infection (URTI), number of sick days per month assessed, number of days required to recover from episode of infection from screening to day 90. 3.Adverse events 4.Palatability with dosage compliance of test productTimepoint: Screening Visit, Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90)

Countries

India

Contacts

Public ContactDr Pranit Ambulkar

Netsurf communication pvt ltd

pranit.a@netsurfnetwork.com9785587317

Outcome results

None listed

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