NCT01917734

Brief Summary

The purpose of this study is to assesses the effectiveness of an integrated model for the management of severe acute malnutrition (IM-SAM) in India comprising facility- and community-based care and using locally-adapted protocols

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,740

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

1.9 years

First QC Date

August 3, 2013

Last Update Submit

August 6, 2013

Conditions

Severe Malnutrition

Keywords

severe acute malnutritionsevere wastingfacility-based carecommunity-based careMadhya PradeshIndia

Outcome Measures

Primary Outcomes (2)

  • Recovery

    Weight gain \>= 15% of initial weight gain

    74 days

  • Discharged

    Proportion of children completing a 14-day stay in the NRC, transitioned to the community phase of the program and atteding at least two of the four community-based follow up visits.

    74 days

Secondary Outcomes (1)

  • Weight gain

    74 days

Other Outcomes (1)

  • Discharged

    74 days

Study Arms (1)

IM-SAM

Children 6-59 months with bilateral pitting edema, and/or WHZ \< - 3 and/or MUAC \< 115 mm.

Other: Therapeutic feeding for children with SAM

Interventions

Therapeutic feeding for children with SAMOTHER

Comparison of outcomes between children with complicated SAM and children with uncomplicated SAM as well as comparisn of outcomes against national and internationally agreed upon standards of care

IM-SAM

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The detection of children with severe acute malnutrition was ensured in the communities by frontline workers in the context of monthly growth monitoring and promotion sessions.

You may qualify if:

  • Age 6-59 months
  • Clinical diagnosis of with bilateral pitting oedema
  • Anthropometric diagnosis of severe wasting (WHZ \< - 3 and/or MUAC \< 115 mm)

You may not qualify if:

  • Severe congenital conditions whose clinical management required highly specialized skills only available ar the district hospital
  • Severe pathological conditions whose clinical management required highly specialized skills only available ar the district hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atal Bal State Nutrition Mission and National Rural Health Mission

Bhopal, Madhya Pradesh, India

Location

Related Publications (1)

  • Aguayo VM, Agarwal V, Agnani M, Das Agrawal D, Bhambhal S, Rawat AK, Gaur A, Garg A, Badgaiyan N, Singh K. Integrated program achieves good survival but moderate recovery rates among children with severe acute malnutrition in India. Am J Clin Nutr. 2013 Nov;98(5):1335-42. doi: 10.3945/ajcn.112.054080. Epub 2013 Sep 25.

    PMID: 24067666DERIVED

MeSH Terms

Conditions

MalnutritionSevere Acute MalnutritionCachexia

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesWeight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Intervention Hierarchy (Ancestors)

MethionineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAmino AcidsAmino Acids, Peptides, and ProteinsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief, Child Nutrition and Development, India

Study Record Dates

First Submitted

August 3, 2013

First Posted

August 7, 2013

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

October 1, 2012

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

IN(1)