Effectiveness of Four Transition Dietary Regimens in the Hospital Management of Children With Kwashiorkor.

October 2, 2023 updated by: University Ghent

The Underlying Causes Affecting the Response to Dietary Rehabilitation in Severely Acutely Malnourished Children at the Center Hôspitalier Universitaire Sourô Sanou, Bobo Dioulasso, Burkina Faso

In Burkina Faso the number of severely acute malnourished (SAM) children successfully treated has increased since the implementation of community-based management of acute malnutrition. SAM children with oedema have a higher risk of dying than SAM without oedema; they require inpatient care. Several theories have been proposed to explain the pathophysiology of oedema in SAM, but its etiology remains unclear. Knowledge on the nutritional adequacy of therapeutic regimens in kwashiorkor is limited. The World Health Organization (WHO) recommends to use in the treatment of complicated SAM a therapeutic milk 'F75' in the stabilization phase; F75+ready-to-use therapeutic foods (RUTF) or F100 at the transition phase. Alternatively the local formulas (maize flour, milk powder, oil, sugar, mineral-vitamin complex CMV) can be used in case of shortage or intolerance.

At the Nutritional Rehabilitation and Education Center of the University Hospital of Bobo Dioulasso it was found that some SAM children whose oedema resolved under F75 in the stabilization phase, re-developed oedema as they entered the transition phase with RUTF. RUTF has the same nutritional value as F100 but contains iron unlike F100 (<0.07 mg/100 mL). It was observed that RUTF in some cases may be associated with higher mortality, probably due to high iron content (10-14 mg/100 g), which may increase the risk of infections and the formation of free radicals, thereby increasing damage to the body's cells. Clinical trials evaluating the current guidelines for the treatment of SAM with oedema are scarce. A better understanding of the risk factors affecting the effectiveness of the nutritional therapeutic protocol for children with Kwashiorkor will be useful to improve their care.

The main objective of this study is to determine whether the use of transition phase diets (Plumpy-Nut®+F75 or F100 or alternative F75+/- CMV+ Plumpy-Nut®) affect oedema resolving in Kwashiorkor children and to investigate the underlying factors for the relapse or non-responsiveness to the therapeutic treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Severe acute malnutrition (SAM) is a life threatening condition that requires urgent attention and appropriate management to reduce mortality and promote recovery among children. SAM is defined by 1) a weight-for-height Z-score more than three standard deviations (SD) below the median based on the 2006 WHO growth standards, 2) a mid-upper arm circumference (MUAC) of less than 115 mm or 3) by the presence of nutritional edema. Signs such as edema, mucocutaneous changes, hepatomegaly, lethargy, anorexia, anemia, severe immune deficiency and rapid progression to mortality characterize a state commonly coined as "complicated SAM". Kwashiorkor (SAM with edema) is one of the forms of complicated SAM commonly distinguished by the unmistakable presence of bipedal edema. Kwashiorkor is characterized by the following clinical signs: 1) edemas symmetrical, painless, soft, bilateral, ascending, pitting; 2) lesions of the skin and integuments; 3) ulcerations and depigmentation; 4) alopecia; 5) constant weight loss marked by edema; 6) hepatomegaly; 7) clinical anemia; 8) intestinal transit disorders: persistent diarrhea, vomiting; 9) anorexia and behavioral disorders (apathy).

Severe acute malnutrition results in high mortality rates of up to half a million child deaths annually. Undernourished children are at higher risk of mortality ranging from three-times more risk among children with moderate malnutrition to 10-times in SAM children compared to well-nourished children.

The objective of this study is to determine whether the use of different transition phase diets affect oedema resolving in Kwashiorkor children and to investigate the underlying factors for the relapse or non-responsiveness to the therapeutic treatment.

Hypotheses to be tested

  • The first hypothesis is that RUTF (Plumpy-Nut®) because of its content in iron may compromise the effectiveness of the transition phase in children with kwashiorkor
  • The second hypothesis is that underlying factors including co-morbidities and epigenetics may explain a difference in response to therapeutic regimens

This is an open label randomized controlled trial to test the effectiveness of four used transition phase diets in Kwashiorkor children in their transition to the rehabilitation phase. The four dietary regimens that will be tested are:

  1. F100;
  2. RUTF+F75;
  3. RUTF+alternative F75 with complex mineral-vitamin (CMV); and
  4. RUTF+alternative F75 without CMV.

When it is decided to move to the transition phase, the child will be assigned to one of the treatments depending on the treatment received during the stabilization phase and the results of the appetite test. That is a child who accepts the Plumpy Nut will receive it in combination with their regimen they had during the stabilization phase. If a child does not accept Plumpy Nut, then they will received F100 regardless of their initial therapeutic food regimen.

  • For those who received F75 in the stabilization phase, they will receive standard F75 + Plumpy Nut
  • For those who received alternative F75 with CMV in the stabilization phase, they will receive alternative F75 with CMV + Plumpy Nut®
  • For those who received alternative F75 without CMV in the stabilization phase, they will receive alternative F75 without CMV + Plumpy Nut®.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
    • Bobo Dioulasso
      • Bobo-Dioulasso, Bobo Dioulasso, Burkina Faso
        • Centre Hospitalier Universitaire Souro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Severe acute malnutrition defined as the presence of edema
  • Who are admitted and treated in the refeeding center (CREN) of the CHUSS
  • Aged between 6 and 59 Months
  • Parental Signed informed consent form
  • Recruited in the first phase of the treatment and successfully admitted to the transition phase

Exclusion Criteria:

  • SAM without edema
  • Moderate acute malnutrition (MAM)
  • Did not improve during the stabilization phase

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard F100
If the test of appetite at the end of the stabilization phase is negative (the child does not accept the Plumpynut)
Dietary supplement: Standard F100
100 kcal and 3 g protein per 100 ml
Experimental: Standard F75+Plumpynut
If the test of appetite at the end of the stabilization phase is positive (the child accepts the Plumpynut) and the child received Standard F75 during the stabilization phase
Dietary supplement: Standard F75 + Plumpynut
Standard F75 with ready to-use therapeutic food (Plumpynut)
Experimental: Alternative F75 with CMV +Plumpynut
If the test of appetite at the end of the stabilization phase is positive (the child accepts the Plumpynut) and the child received Alternative F75 with CMV during the stabilization phase
Dietary supplement: Alternative F75 with CMV + Plumpynut
Alternative F75 containing CMV with ready to-use therapeutic food (Plumpynut)
Experimental: Alternative F75 without CMV +Plumpynut
If the test of appetite at the end of the stabilization phase is positive (the child accepts the Plumpynut) and the child received Alternative F75 without CMV during the stabilization phase
Dietary supplement: Alternative F75 without CMV + Plumpynut
Alternative F75 with no CMV with ready to-use therapeutic food (Plumpynut)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edema redevelopment during the transition phase
Time Frame: Three to Seven days
Number of children whose edema redeveloped after it has been resolved during the stabilization phase
Three to Seven days
Severe adverse event
Time Frame: Three to Seven days
Any serious severe adverse event ranging from diarrhea, vomiting, anorexia to death
Three to Seven days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean number of days for a complete edema resolving
Time Frame: Three to Seven days
Number of days for a complete edema resolving among Kwashiorkor children, in Day
Three to Seven days
Intestinal microbiota
Time Frame: Three to Seven days
16S rRNA sequencing of DNA extracts of fecal samples
Three to Seven days
Presence of acidic stools
Time Frame: Three to Seven days
Measurement of stool potential Hydrogen (pH)
Three to Seven days
Soil Helminths
Time Frame: Three to Seven days
Determination of intestinal parasites using Quantitative Real-Time polymerase chain reaction (qPCR)
Three to Seven days
Epigenetics
Time Frame: Three to Seven days
In a subsample of children, DNA methylation is identified using Illumina Array Analysis Platform
Three to Seven days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

Institut de Recherche en Sciences de la Sante, Burkina Faso
Centre Muraz
University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso)

Investigators

  • Principal Investigator: Stefaan De Henauw, Md. PhD, University of Ghent
  • Principal Investigator: Souheila Abbeddou, MSc. PhD, University of Ghent
  • Principal Investigator: Jerome Some, Md. PhD, Institut de Recherche en Sciences de la Sante, Burkina Faso
  • Principal Investigator: Bintou Sanogo, MSc. Md., Centre Hospitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-09443-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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