Community Based Management of Malnutrition

NCT00941434 | Completed

• 1 other identifier: 1227-Ped/ERC-09
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Malnutrition is the leading cause of death in children in developing countries, especially Pakistan. According to World Health Organization about 60% of all deaths, occurring among children aged less than five years in developing countries, could be attributed to malnutrition. Community-based therapeutic care attempts to maximize population-level impact through improved coverage, access, and cost-effectiveness of treatment. Such community-based nutrition packages can provide effective care to the majority of acutely malnourished children as outpatients, using techniques of community mobilization to engage the affected population and maximize coverage and compliance. Children with SAM without medical complications are treated in an outpatient therapeutic program with ready-to-use therapeutic food and routine medications. The Ready-to-use Therapeutic Food (RUTF) and Fortified Supplementary food has revolutionized the treatment of moderate and severe malnutrition. The advantage of these commodities is that they are ready-to-use paste which does not need to be mixed with water, thereby avoiding the risk of bacterial proliferation in case of accidental contamination.

Conditions

Severe and Moderate Malnutrition

Keywords

RUTF; SAM; Nutributter

Outcome Measures

Primary Outcomes (1)

• Improved Growth Parameters Weight for Age Z Scores.

  1 year

Secondary Outcomes (1)

• Reduction in Malnutrition related morbidity and mortality patterns in early childhood

  1 year

Study Arms (1)

RUTF

EXPERIMENTAL

Children with Severe malnutrition will be treated with Ready to use therapeutic food (RUTF) till their weight for age z scores are no longer in severe malnutrition group

Dietary Supplement: RUTF

Interventions

RUTF DIETARY_SUPPLEMENT

Children with severe malnutrition will be treated with a daily dose of RUTF till their weight for age z scores no longer fall in severe malnutrition group

RUTF

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Presence of moderate to severe malnutrition.
• Ability of the parents or guardians to provide informed consent

You may not qualify if:

• Presence of chronic debilitating illness.
• Residence outside of study areas.
• Inability or refusal of the parents or guardians to give informed consent, or refusal of assessment.

Sponsors & Collaborators

• Aga Khan University: lead
• John Snow, Inc.: collaborator
• Pakistan Ministry of Health: collaborator

Study Sites (1)

AKU Project Office

Dadu, Sindh, Pakistan

Location

Study Officials

• Dr. Zulfiqar A. Bhutta, MBBS, FRCP, FCPS, PhD

  Women and Child Health Division, Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 17, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 8, 2011

Record last verified: 2009-07

Locations

PA (1)