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Community Based Management of Malnutrition

Primary Purpose

Severe and Moderate Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
RUTF
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe and Moderate Malnutrition focused on measuring RUTF, SAM, Nutributter

Eligibility Criteria

6 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AKU Project Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RUTF

Arm Description

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

Outcomes

Primary Outcome Measures

Improved Growth Parameters Weight for Age Z Scores.

Secondary Outcome Measures

Reduction in Malnutrition related morbidity and mortality patterns in early childhood

Full Information

First Posted
July 16, 2009
Last Updated
July 7, 2011
Sponsor
Aga Khan University
Collaborators
John Snow, Inc., Pakistan Ministry of Health
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1. Study Identification

Unique Protocol Identification Number
NCT00941434
Brief Title
Community Based Management of Malnutrition
Official Title
Community Based Management of Malnutrition. A Proposal for Pakistan Initiative for Mothers and Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aga Khan University
Collaborators
John Snow, Inc., Pakistan Ministry of Health

4. Oversight

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe and Moderate Malnutrition
Keywords
RUTF, SAM, Nutributter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RUTF
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
RUTF
Intervention Description
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
Primary Outcome Measure Information:
Title
Improved Growth Parameters Weight for Age Z Scores.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Reduction in Malnutrition related morbidity and mortality patterns in early childhood
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Zulfiqar A. Bhutta, MBBS, FRCP, FCPS, PhD
Organizational Affiliation
Women and Child Health Division, Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AKU Project Office
City
Dadu
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Community Based Management of Malnutrition

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