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Community Based Management of Malnutrition

This study has been completed.
Sponsor:
Collaborators:
John Snow, Inc.
Pakistan Ministry of Health
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00941434
First received: July 16, 2009
Last updated: July 7, 2011
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention
Severe and Moderate Malnutrition
 Dietary Supplement: RUTF

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Community Based Management of Malnutrition. A Proposal for Pakistan Initiative for Mothers and Newborns

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Improved Growth Parameters Weight for Age Z Scores. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in Malnutrition related morbidity and mortality patterns in early childhood [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RUTF
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
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

Detailed Description:

Aim:

To evaluate the effectiveness of Ready to Use Therapeutic food and food supplement (Nutributter) in the treatment of Moderate and Severe malnutrition in rural Pakistan when administered at community level

Primary objectives:

  • To assess the acceptability, feasibility and effectiveness of Nutributter and Fortified supplementary food (RUTF) in the treatment of moderate malnutrition in children less than three years of age in community settings.
  • To assess the acceptability, feasibility and effectiveness of RUTF in the treatment of severe malnutrition in children less than three years of age in community settings.

Methodology:

Study Design: Community based, step wedge randomized trial

Sample size estimation:

Total Population of the study area: 60268. Estimated under 5 years of age Population: 9040 (Assuming 15% of Total population. Estimated Population between 6 months to 3 years: 4520 (Assuming 50% of Under 5 Population)

Sample Size for Moderate Malnutrition:

It is estimated that the Prevalence of Moderately Malnourished: 20% Therefore 20% of 4520: 904. We anticipate recruiting 1000 cases (96 about 10% extra for any loss to follow-ups or drop outs)

Sample Size For Severe Malnutrition:

It is estimated that the prevalence of Severe Acute Malnutrition is 8%. Therefore 8% of 4520: 360. We anticipate recruiting 400 cases (40 about 10% extra for any loss to follow-ups or drop outs)

  Eligibility

Ages Eligible for Study:   6 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Born and eligible for inclusion within the study period.
  • Presence of moderate to severe malnutrition.
  • Ability of the parents or guardians to provide informed consent

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941434

Locations
Pakistan
AKU Project Office
Dadu, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
John Snow, Inc.
Pakistan Ministry of Health
Investigators
Principal Investigator: Dr. Zulfiqar A. Bhutta, MBBS, FRCP, FCPS, PhD Women and Child Health Division, Aga Khan University
  More Information

No publications provided

Responsible Party: Prof. Zulfiqar A Bhutta, Aga Khan University
ClinicalTrials.gov Identifier: NCT00941434     History of Changes
Other Study ID Numbers: 1227-Ped/ERC-09
Study First Received: July 16, 2009
Last Updated: July 7, 2011
Health Authority: Pakistan: Ministry of Health

Keywords provided by Aga Khan University:
RUTF
SAM
Nutributter

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 19, 2013