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Effects of Three Feeding Regimens on Recovery of Uncomplicated Severely Acute Malnourished Children (SAMPOORNA)

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ClinicalTrials.gov Identifier: NCT01705769
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : June 8, 2015
Sponsor:
Collaborators:
Action Research and Training for Health (ARTH), Udaipur
Christian Medical College, Vellore, India
World Health Organization
Information provided by (Responsible Party):
NBhandari, Society for Applied Studies

Brief Summary:
This project aims to assess the efficacy of three options under consideration in India for home management of Severe Acute Malnutrition (SAM). The investigators propose to conduct a multi-center randomized controlled trial to determine the efficacy of two community-supported home-based regimes using centrally or locally produced Ready to Use Therapeutic Foods (RUTF) for recovery from uncomplicated SAM after 16 weeks of management, compared with an augmented home-prepared foods regimen. The trial will enroll 911 children with uncomplicated SAM and will have enough statistical power to detect a 15% or greater difference in recovery rates between either one of the intervention groups compared with comparison group.

Condition or disease Intervention/treatment Phase
Uncomplicated Severe Acute Malnutrition Other: Ready to Use Therapeutic Food-Centrally produced Other: Ready to Use Therapeutic Food-Locally produced Other: High energy and micronutrient rich foods Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 911 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Evaluate the Impact of Three Feeding Regimens on the Recovery of Children From Uncomplicated Severe Acute Malnutrition (SAM) in India and to Use the Evidence to Inform National Policy
Study Start Date : October 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: RUTF-Centrally produced
Ready to Use Therapeutic Food-Centrally produced by an Indian company
Other: Ready to Use Therapeutic Food-Centrally produced
Ready to Use Therapeutic Food-Centrally produced by an Indian company.

Experimental: RUTF-Locally produced
Ready to Use Therapeutic Food-Locally produced by the study team at each study site
Other: Ready to Use Therapeutic Food-Locally produced
Ready to Use Therapeutic Food prepared by the study team

Active Comparator: High energy and micronutrient rich foods
High energy and micronutrient rich foods prepared by caregivers at home using ingredients provided to them
Other: High energy and micronutrient rich foods
High energy and micronutrient rich foods prepared by caregivers at home using ingredients provided to them




Primary Outcome Measures :
  1. Recovery by 16 weeks after enrollment (defined as achieving weight for height greater than or equal to -2 SD and absence of oedema of both feet) [ Time Frame: Weekly till recovery or 16 weeks after enrollment, whichever is earlier ]

Secondary Outcome Measures :
  1. Mortality and hospitalizations [ Time Frame: Weekly till 16 weeks or recovery and at end of sustenance phase ]
  2. Rate of weight gain (grams/kg body wt/day) [ Time Frame: From enrollment till recovery or 16 weeks whichever is earlier ]
  3. Time required to reach recovery [ Time Frame: From enrollment till recovery or 16 weeks whichever is earlier ]
  4. Íncidence and prevalence of diarrhea, ARI and fever during treatment phase [ Time Frame: From enrollment till recovery or 16 weeks whichever is earlier ]
  5. Proportion of children with weight for height greater than or equal to -2 SD and absence of oedema of feet [ Time Frame: At the end of sustenance phase ]
  6. Cost of three feeding regimens [ Time Frame: Enrollment to end of treatment phase ]
  7. Feedback from families, health care providers and ICDS functionaries about the feeding regimens regarding perceptions and feasibility of use [ Time Frame: Enrollment to end study ]
  8. Factors which affect recovery [ Time Frame: At 16 weeks post enrolment in those that have not recovered ]
  9. Perception of families regarding anganwadi centre experiences at the end of sustenance phase [ Time Frame: from end of treatment phase to end of sustanence phase ]


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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6 to 59 months
  • SAM, defined as Weight for height less than -3 SD of WHO standard or oedema of both feet or both.

Exclusion Criteria:

  • Complicated SAM defined as child with SAM having signs of severe illness requiring hospitalization
  • Known allergy to animal milk or peanuts
  • Likely to leave the study area permanently in the next 16 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705769


Locations
India
Centre for Health Research and Development, Society for Applied Studies
New Delhi, Delhi, India, 110062
Action Research & Training for Health (ARTH)
Udaipur, Rajasthan, India, 313004
Christian Medical College
Vellore, Tamil Nadu, India, 632002
Sponsors and Collaborators
Society for Applied Studies
Action Research and Training for Health (ARTH), Udaipur
Christian Medical College, Vellore, India
World Health Organization
Investigators
Principal Investigator: Nita Bhandari, MD, PhD Centre for Health Research and Development, Society for Applied Studies

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NBhandari, Director, Society for Applied Studies
ClinicalTrials.gov Identifier: NCT01705769     History of Changes
Other Study ID Numbers: RPC538
CTRI/2012/10/003054 ( Registry Identifier: Clinical Trial Registry - India )
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by NBhandari, Society for Applied Studies:
treatment
severe acute malnutrition

Additional relevant MeSH terms:
Malnutrition
Severe Acute Malnutrition
Nutrition Disorders
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs