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Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

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ClinicalTrials.gov Identifier: NCT02053857
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : September 29, 2014
Sponsor:
Collaborator:
University of Malawi
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Kwashiorkor Marasmus Dietary Supplement: RUTF Dietary Supplement: RUTF-P Drug: Amoxicillin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Active Comparator: RUTF
Standard RUTF at a dose of 175 kcal/kg/d
Dietary Supplement: RUTF
Other Name: ready-to-use therapeutic food

Drug: Amoxicillin
Experimental: RUTF-P
RUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d
Dietary Supplement: RUTF-P
Drug: Amoxicillin



Primary Outcome Measures :
  1. DHA Level [ Time Frame: 4 weeks ]
    Blood plasma docosahexaenoic acid (DHA) levels

  2. EPA Level [ Time Frame: 4 weeks ]
    Blood plasma eicosapentaenoic acid (EPA) levels


Secondary Outcome Measures :
  1. Recovery Rate [ Time Frame: 12 weeks ]
    Proportion of children who recover from SAM

  2. Linear Growth [ Time Frame: 12 weeks ]
    Changes in length

  3. Ponderal Growth [ Time Frame: 12 weeks ]
    Changes in weight

  4. Growth [ Time Frame: 12 weeks ]
    Changes in mid-upper-arm circumference



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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:

  • 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

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): NCT02053857


Locations
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Malawi
University of Malawi College of Medicine
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
University of Malawi
Investigators
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Principal Investigator: Mark J Manary, MD Washington University School of Medicine
Principal Investigator: Kenneth Maleta, MBBS PhD University of Malawi
Principal Investigator: Chrissie Thakwalakwa University of Malawi

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02053857     History of Changes
Other Study ID Numbers: PUFA-RUTF Pilot
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: September 29, 2014
Last Verified: September 2014

Keywords provided by Washington University School of Medicine:
severe acute malnutrition
polyunsaturated fatty acids
ready-to-use therapeutic food

Additional relevant MeSH terms:
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Malnutrition
Severe Acute Malnutrition
Kwashiorkor
Protein-Energy Malnutrition
Nutrition Disorders
Protein Deficiency
Deficiency Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents