search
Back to results

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

Primary Purpose

Severe Acute Malnutrition, Kwashiorkor, Nutritional Edema

Status
Completed
Phase
Not Applicable
Locations
Burkina Faso
Study Type
Interventional
Intervention
Standard F100
Standard F75 + Plumpynut
Alternative F75 with CMV + Plumpynut
Alternative F75 without CMV + Plumpynut
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Malnutrition focused on measuring Severe acute malnutrition, Nutritional rehabilitation, F100, Transition phase, Therapeutic complex of vitamins and minerals (CMV), Kwashiorkor, Ready-to-use Therapeutic Food

Eligibility Criteria

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

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

Sites / Locations

  • Centre Hospitalier Universitaire Souro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Standard F100

Standard F75+Plumpynut

Alternative F75 with CMV +Plumpynut

Alternative F75 without CMV +Plumpynut

Arm Description

If the test of appetite at the end of the stabilization phase is negative (the child does not accept the 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

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

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

Outcomes

Primary Outcome Measures

Edema redevelopment during the transition phase
Number of children whose edema redeveloped after it has been resolved during the stabilization phase
Severe adverse event
Any serious severe adverse event ranging from diarrhea, vomiting, anorexia to death

Secondary Outcome Measures

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

Full Information

First Posted
August 2, 2021
Last Updated
October 2, 2023
Sponsor
University Ghent
Collaborators
Institut de Recherche en Sciences de la Sante, Burkina Faso, University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso), Centre Muraz
search

1. Study Identification

Unique Protocol Identification Number
NCT05015257
Brief Title
Effectiveness of Four Transition Dietary Regimens in the Hospital Management of Children With Kwashiorkor.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Institut de Recherche en Sciences de la Sante, Burkina Faso, University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso), Centre Muraz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: F100; RUTF+F75; RUTF+alternative F75 with complex mineral-vitamin (CMV); and 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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Malnutrition, Kwashiorkor, Nutritional Edema
Keywords
Severe acute malnutrition, Nutritional rehabilitation, F100, Transition phase, Therapeutic complex of vitamins and minerals (CMV), Kwashiorkor, Ready-to-use Therapeutic Food

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is an open label randomized controlled trial to test the effectiveness of four diets in Kwashiorkor children in their transition phase. 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®.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard F100
Arm Type
Active Comparator
Arm Description
If the test of appetite at the end of the stabilization phase is negative (the child does not accept the Plumpynut)
Arm Title
Standard F75+Plumpynut
Arm Type
Experimental
Arm Description
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
Arm Title
Alternative F75 with CMV +Plumpynut
Arm Type
Experimental
Arm Description
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
Arm Title
Alternative F75 without CMV +Plumpynut
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard F100
Intervention Description
100 kcal and 3 g protein per 100 ml
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard F75 + Plumpynut
Intervention Description
Standard F75 with ready to-use therapeutic food (Plumpynut)
Intervention Type
Dietary Supplement
Intervention Name(s)
Alternative F75 with CMV + Plumpynut
Intervention Description
Alternative F75 containing CMV with ready to-use therapeutic food (Plumpynut)
Intervention Type
Dietary Supplement
Intervention Name(s)
Alternative F75 without CMV + Plumpynut
Intervention Description
Alternative F75 with no CMV with ready to-use therapeutic food (Plumpynut)
Primary Outcome Measure Information:
Title
Edema redevelopment during the transition phase
Description
Number of children whose edema redeveloped after it has been resolved during the stabilization phase
Time Frame
Three to Seven days
Title
Severe adverse event
Description
Any serious severe adverse event ranging from diarrhea, vomiting, anorexia to death
Time Frame
Three to Seven days
Secondary Outcome Measure Information:
Title
Mean number of days for a complete edema resolving
Description
Number of days for a complete edema resolving among Kwashiorkor children, in Day
Time Frame
Three to Seven days
Title
Intestinal microbiota
Description
16S rRNA sequencing of DNA extracts of fecal samples
Time Frame
Three to Seven days
Title
Presence of acidic stools
Description
Measurement of stool potential Hydrogen (pH)
Time Frame
Three to Seven days
Title
Soil Helminths
Description
Determination of intestinal parasites using Quantitative Real-Time polymerase chain reaction (qPCR)
Time Frame
Three to Seven days
Title
Epigenetics
Description
In a subsample of children, DNA methylation is identified using Illumina Array Analysis Platform
Time Frame
Three to Seven days

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefaan De Henauw, Md. PhD
Organizational Affiliation
University of Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Souheila Abbeddou, MSc. PhD
Organizational Affiliation
University of Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jerome Some, Md. PhD
Organizational Affiliation
Institut de Recherche en Sciences de la Sante, Burkina Faso
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bintou Sanogo, MSc. Md.
Organizational Affiliation
Centre Hospitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Souro
City
Bobo-Dioulasso
State/Province
Bobo Dioulasso
Country
Burkina Faso

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary
Citations:
PubMed Identifier
1306670
Citation
Gopalan C. Kwashiorkor and marasmus: evolution and distinguishing features. 1968. Natl Med J India. 1992 May-Jun;5(3):145-51. No abstract available.
Results Reference
background
PubMed Identifier
26587175
Citation
Nguefack F, Adjahoung CA, Keugoung B, Kamgaing N, Dongmo R. [Hospital management of severe acute malnutrition in children with F-75 and F-100 alternative local preparations: results and challenges]. Pan Afr Med J. 2015 Aug 31;21:329. doi: 10.11604/pamj.2015.21.329.6632. eCollection 2015. French.
Results Reference
background
PubMed Identifier
24277964
Citation
Singh K, Badgaiyan N, Ranjan A, Dixit HO, Kaushik A, Kushwaha KP, Aguayo VM. Management of children with severe acute malnutrition: experience of Nutrition Rehabilitation Centers in Uttar Pradesh, India. Indian Pediatr. 2014 Jan;51(1):21-5. doi: 10.1007/s13312-014-0328-9. Epub 2013 Jul 5.
Results Reference
background
PubMed Identifier
23363771
Citation
Smith MI, Yatsunenko T, Manary MJ, Trehan I, Mkakosya R, Cheng J, Kau AL, Rich SS, Concannon P, Mychaleckyj JC, Liu J, Houpt E, Li JV, Holmes E, Nicholson J, Knights D, Ursell LK, Knight R, Gordon JI. Gut microbiomes of Malawian twin pairs discordant for kwashiorkor. Science. 2013 Feb 1;339(6119):548-54. doi: 10.1126/science.1229000. Epub 2013 Jan 30.
Results Reference
background
Links:
URL
https://www.who.int/publications/i/item/9789241506328
Description
World Health Organization (2013) WHO guideline: updates on the management of severe acute malnutrition in infants and children
URL
https://www.unicef.fr/article/malnutrition-la-situation-au-burkina-faso
Description
Enquête Nutritionnelle Nationale SMART 2016 au Burkina Faso. 2016 ; 47p
URL
https://www.humanitarianresponse.info/sites/www.humanitarianresponse.info/files/documents/files/protocole_pcima_bf_janv_2015.pdf
Description
Ministère de la Sante au Burkina Faso. Protocol National : Prise en charge intégrée de la malnutrition aigüe (PCIMA). 2014

Learn more about this trial

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

We'll reach out to this number within 24 hrs