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Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

Primary Purpose

Kwashiorkor, Marasmus

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
RUTF
RUTF-P
Amoxicillin
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kwashiorkor focused on measuring severe acute malnutrition, polyunsaturated fatty acids, ready-to-use therapeutic food

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • kwashiorkor and/or marasmus
  • 6-59 months of age
  • lives in local area near enrollment site

Exclusion Criteria:

  • recent (<4 months) therapeutic feeding for moderate or severe acute malnutrition
  • chronic medical condition (eg, Down syndrome, other congenital syndrome, chronic heart disease) that may make feeding and growth difficult (not to include HIV or TB)
  • caretaker refusal of 2 blood draws
  • ineligibility for outpatient therapy (ie, severe illness or anorexia requiring inpatient therapy)
  • caretaker expresses plans to move away from local area of clinic, making followup difficult

Sites / Locations

  • University of Malawi College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RUTF

RUTF-P

Arm Description

Standard RUTF at a dose of 175 kcal/kg/d

RUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d

Outcomes

Primary Outcome Measures

DHA Level
Blood plasma docosahexaenoic acid (DHA) levels
EPA Level
Blood plasma eicosapentaenoic acid (EPA) levels

Secondary Outcome Measures

Recovery Rate
Proportion of children who recover from SAM
Linear Growth
Changes in length
Ponderal Growth
Changes in weight
Growth
Changes in mid-upper-arm circumference

Full Information

First Posted
January 31, 2014
Last Updated
September 26, 2014
Sponsor
Washington University School of Medicine
Collaborators
University of Malawi
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1. Study Identification

Unique Protocol Identification Number
NCT02053857
Brief Title
Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition
Official Title
A Randomized, Double-blind Pilot Study of Polyunsaturated Fatty Acid-optimized Ready-to-use Therapeutic Food, Compared to Standard RUTF, in the Therapy of Severe Acute Malnutrition
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of Malawi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as standard RUTF.
Detailed Description
Since 2007, RUTF has been the recommended treatment for SAM. RUTF is not conducive to the growth of bacteria because of the low moisture content, does not require cooking, and has led to greater recovery rates than liquid milk formulations in direct comparisons. One expected benefit of the RUTF-P is improved outcomes due to the higher levels of essential fatty acids. The essential fatty acid profile (i.e., the level of omega-3 and omega-6 fatty acids) of RUTF-P may have important implications for cognitive development of children, especially infants, with SAM who consume these foods as their sole dietary source for several weeks. In particular, an excess of omega-6 fatty acids (from sources such as peanut and corn oil) and a minimum of omega-3 fatty acids (from sources like flax) may fail to support optimal cognitive development and neural function. In this prospective, double-blinded, randomized controlled clinical effectiveness trial, we will compare two RUTF products in the treatment of SAM to test the effects of the two different RUTF products on essential fatty acid status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kwashiorkor, Marasmus
Keywords
severe acute malnutrition, polyunsaturated fatty acids, ready-to-use therapeutic food

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RUTF
Arm Type
Active Comparator
Arm Description
Standard RUTF at a dose of 175 kcal/kg/d
Arm Title
RUTF-P
Arm Type
Experimental
Arm Description
RUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d
Intervention Type
Dietary Supplement
Intervention Name(s)
RUTF
Other Intervention Name(s)
ready-to-use therapeutic food
Intervention Type
Dietary Supplement
Intervention Name(s)
RUTF-P
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Primary Outcome Measure Information:
Title
DHA Level
Description
Blood plasma docosahexaenoic acid (DHA) levels
Time Frame
4 weeks
Title
EPA Level
Description
Blood plasma eicosapentaenoic acid (EPA) levels
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Recovery Rate
Description
Proportion of children who recover from SAM
Time Frame
12 weeks
Title
Linear Growth
Description
Changes in length
Time Frame
12 weeks
Title
Ponderal Growth
Description
Changes in weight
Time Frame
12 weeks
Title
Growth
Description
Changes in mid-upper-arm circumference
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: kwashiorkor and/or marasmus 6-59 months of age lives in local area near enrollment site Exclusion Criteria: recent (<4 months) therapeutic feeding for moderate or severe acute malnutrition chronic medical condition (eg, Down syndrome, other congenital syndrome, chronic heart disease) that may make feeding and growth difficult (not to include HIV or TB) caretaker refusal of 2 blood draws ineligibility for outpatient therapy (ie, severe illness or anorexia requiring inpatient therapy) caretaker expresses plans to move away from local area of clinic, making followup difficult
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Manary, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Maleta, MBBS PhD
Organizational Affiliation
University of Malawi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chrissie Thakwalakwa
Organizational Affiliation
University of Malawi
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malawi College of Medicine
City
Blantyre
Country
Malawi

12. IPD Sharing Statement

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Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

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