Completed

NCT Number: NCT00941434

Community Based Management of Malnutrition

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.

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Key information

Conditions

Severe and Moderate Malnutrition

Age range

6 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AKU Project Office

Dadu, Sindh, Pakistan

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

Improved Growth Parameters Weight for Age Z Scores.

Time frame: 1 year

Secondary outcomes

Reduction in Malnutrition related morbidity and mortality patterns in early childhood

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

John Snow, Inc.
Pakistan Ministry of Health

Registry information

Official study title

Community Based Management of Malnutrition. A Proposal for Pakistan Initiative for Mothers and Newborns

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jul 17, 2009
Registry last updated: Jul 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.