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A Clinical Trial to Evaluate the Effects of Nutritional Supplements in Children Aged 2 to 6 Years with Mild to Moderate Acute Malnutrition in the Sub-Urban Regions of India

Effect Of Indigenously Prepared Nutritional Supplement In Children With Mild To Moderate Acute Malnutrition In India Sub-Urban Region - A Prospective Facility-Based Study - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078745
Enrollment
1000
Registered
2024-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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: 15 gram Nutritional supplement with 150 ml of milk for 90 days: 15 gram Nutritional supplement with 150 ml of milk in the morning for 90 days Control Intervention1: 150 ml of milk for 9

Sponsors

Netsurf Communication Pvt Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The subjects should follow following inclusion criteria to participate in the study- 1. Children in between 2 -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 acute mild to moderate stage of Malnutrition 4. Patients with PEM

Exclusion criteria

Exclusion criteria: The subjects should not present any of the following 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 severe acute malnutrition

Design outcomes

Primary

MeasureTime frame
The primary objectives of the study will be to evaluate- •Growth- Change in weight and height (WHO z-score) •Improvement-Change in mid arm circumferenceTimepoint: Screening Visit (up to -7 days) to Visit 3 (Day 90 ± 5 days)

Secondary

MeasureTime frame
The secondary objectives of the study will be to evaluate- • No. of days required to recover from episode of infection • Eating Behavior Questionnaire (CEBQ) • Emotional Quotient Questionnaire (EQQ) • Assessment of Overall Improvement by parent & investigator Timepoint: Screening Visit (up to -7 days) to Visit 3 (Day 90 ± 5 days)

Countries

India

Contacts

Public ContactDr Mangesh Shende

Netsurf Communication Pvt Ltd.

pranit.a@netsurfdirect.com9785587317

Outcome results

None listed

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