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Effectiveness of Alternative Diets During the Stabilization Phase on Children With Complicated SAM

Primary Purpose

Severe Acute Malnutrition, Kwashiorkor, Nutritional Edema

Status
Recruiting
Phase
Not Applicable
Locations
Burkina Faso
Study Type
Interventional
Intervention
Standard F75
Alternative F75 with CMV
Alternative F75 without CMV
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, F75, Stabilization phase, Therapeutic complex of vitamins and minerals (CMV), Kwashiorkor, Marasmus

Eligibility Criteria

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

Inclusion Criteria:

  • Severe acute malnutrition defined as Weight-for-Height Z-score (WHZ) <- 3 SD AND / OR MUAC <115 mm AND / OR with edema
  • With complications
  • Who are admitted and treated in the refeeding center (CREN) of the CHUSS
  • Aged between 6 and 59 Months
  • Parental Signed informed consent form

Exclusion Criteria:

  • Children younger than 6 months or older than 59 months of age
  • Moderate Acute Malnutrition (MAM)

Sites / Locations

  • Centre Hospitalier Universitaire SouroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard F75

Alternative F75 with CMV

Alternative F75 without CMV

Arm Description

At the admission, therapeutic food is given by the nurses every 2 hours on the first day; then if tolerance is good, every 3 hours the following days. No family meals during the stabilization phase. But the baby can breastfeed. A child will receive an antibiotic as per the national protocol, malaria treatment if diagnosed with malaria, Vitamin A if symptomatic eye damage, Folic acid in case of anemia, antifungal in case of candidiasis.

At the admission, therapeutic food is given by the nurses every 2 hours on the first day; then if tolerance is good, every 3 hours the following days. No family meals during the stabilization phase. But the baby can breastfeed. A child will receive an antibiotic as per the national protocol, malaria treatment if diagnosed with malaria, Vitamin A if symptomatic eye damage, Folic acid in case of anemia, antifungal in case of candidiasis.

At the admission, therapeutic food is given by the nurses every 2 hours on the first day; then if tolerance is good, every 3 hours the following days. No family meals during the stabilization phase. But the baby can breastfeed. A child will receive an antibiotic as per the national protocol, malaria treatment if diagnosed with malaria, Vitamin A if symptomatic eye damage, Folic acid in case of anemia, antifungal in case of candidiasis.

Outcomes

Primary Outcome Measures

Recovery rate of children
Number of children treated and admitted to the transition phase
Daily weight gain
Average daily weight gain in the stabilization phase in Grams
Number of days during the first phase of treatment
Average number of days spent in the stabilization phase in Day

Secondary Outcome Measures

% of intake of the therapeutic regimen
Daily intake of the administered dietary treatment
Anorexia
Serious severe event that occurs at anytime during the treatment
Mortality
Serious severe event that occurs at anytime during the treatment
Diarrhea
Serious severe event that occurs at anytime during the treatment
Vomiting
Serious severe event that occurs at anytime during the treatment

Full Information

First Posted
August 2, 2021
Last Updated
November 25, 2022
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
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1. Study Identification

Unique Protocol Identification Number
NCT05020847
Brief Title
Effectiveness of Alternative Diets During the Stabilization Phase on Children With Complicated SAM
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
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 9, 2024 (Anticipated)

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
Severe acute malnutrition (SAM) is a life threatening condition and is defined by 1) a weight-for-height Z-score more than three standard deviations (SD) below the median based on the 2006 World Health Organization (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 is one of the forms of complicated SAM commonly distinguished by the unmistakable presence of bipedal edema. SAM 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. Children with complicated SAM require inpatient treatment in specialized centers. The "Rehabilitation and Nutritional Education Center" (CREN) is a specialized center in Burkina Faso receiving on average 10 SAM children per day. Recovery rate is lower than international standards; and adverse events and mortality remain strikingly high. Our main objective is to assess the underlying risk factors affecting the effectiveness of the nutritional therapeutic treatment protocol for complicated SAM children under 5 years of age who have been referred to the CREN, at the Centre Hôspitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso. The specific objective is to assess the effectiveness of alternative dietary regimens during the stabilization phase on well-specified clinical and biochemical outcomes in children with complicated SAM. Dietary regimens differ by their carbohydrate profile and content, and by their different micronutrient composition including vitamin A, iron and zinc.
Detailed Description
Severe acute malnutrition (SAM), defined as severe wasting [weight-to-height Z-score < -3 standard deviations (SD), based on the WHO Child Growth Standards] and / or the presence of nutritional edema, and / or mid-upper arm circumference (MUAC) <115 mm, is a condition that requires urgent attention and appropriate management to reduce mortality and promote recovery among children. Management of SAM children without complications is provided at the community level. Hospitalization in specialized care centers is necessary for SAM children with complications. SAM children with comorbidities have a greater risk of mortality and treatment failure. Our knowledge of the specific adequate nutritional needs of SAM is limited. For the treatment of SAM in hospital, the WHO recommends the use of therapeutic milk low in protein 'F75' in the stabilization phase; and more protein-rich F100 or F75 combined with ready-to-use therapeutic foods (RUTF) in the transition phase. The WHO also recommends using as an alternative formula made of cereal flour, skimmed milk powder, oil, sugar, and a therapeutic vitamin and mineral complex (CMV), in case of shortage of the standard therapeutic milk F75 / F100 or in case of signs of intolerance (vomiting, diarrhea). The Refeeding Center - Centre de Récupération et d'Education Nutritionnelle (CREN) of the Sourô Sanou University Hospital Center (CHUSS) in Burkina Faso specializes in the care of SAM children with complications. In 2018, out of 500 children aged 6-59 months admitted for SAM with complications, the CHUSS CREN registered 86.8% full recovery, 8.2% dropout and 5% death. Although the recovery rate is higher than international standards (greater than 75%), the mortality rate remains higher than the recommended 3% by international standards; in addition to the challenges that are faced locally in maintaining high standards of care. At the CREN, we observed that some SAM children with complications can have severe diarrhea and vomiting after taking F75 (first phase of the nutritional treatment). It was also observed that other SAM children with edema, whose edema resolved in the first phase of treatment under F75, redeveloped edema when they received RUTF (Plumpy Nut®) in the transition phase according to the WHO 2013 protocol. The second objective of the study is to assess the risk factors affecting the response to dietary treatment in this center (the CREN, Burkina Faso) and to compare alternatives for treatment during the nutritional rehabilitation. Problematic It was observed at the Refeeding Center (CREN) of the Sourô Sanou University Hospital (CHUSS) in Bobo Dioulasso, that SAM children with complications show during their treatment, signs of intolerance to F75 (diarrhea , vomiting). The pathophysiology of diarrhea in SAM involves several theories including that of lactose intolerance, and that of alteration of the intestinal microbiota. The study aims to assess the effectiveness of diet regimens [standard F75, or alternative F75 + mineral vitamin complex (CMV), or alternative F75 without CMV] during the stabilization phase from both a clinical and biochemical aspects in children with complicated SAM. Diets differ in their profile and carbohydrate content, and in their different micronutrient compositions, including vitamin A, iron and zinc. Our hypothesis is that the F75 alternative during the stabilization phase (the first phase) of complicated SAM children is associated with better compliance, less diarrhea and better outcomes than the recommended F75 formulation; and that children treated correctly with the F75 alternative containing CMV will perform better than the other two groups of children treated with F75 or the F75 alternative without CMV. This will be an open, randomized controlled trial aimed at testing the effectiveness of three therapeutic diet regimens during the first phase of hospital management of children with complicated SAM admitted to CREN, Bobo Dioulasso. After obtaining informed consent from parents / guardians for the inclusion of the child, the child will be randomized and will receive their assigned treatment. In accordance with the 2014 protocol for the management of SAM in Burkina Faso, an antibiotic will be given as part of the systematic treatment of complicated SAM, and other medical treatments depending on the associated complication. Deworming is provided also gratis, will be done only in children whose tests are positive for intestinal parasites and ONLY in the rehabilitation phase (the third phase of the treatment) as per the National Protocol for the management of complicated SAM. The dietetic treatment will be given by the nurses every 2 hours on the first day; then if tolerance is good, every 3 hours the following days. No family meals during phase 1. But the baby can breastfeed. The observance and tolerance of the treatment will be noted by the nurses: amount of milk taken, refusal, vomiting, diarrhea, presence of a nasogastric tube. The quantities will be given according to the weight of the child, the presence or not of edema, in accordance with the national protocol.

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, Marasmus
Keywords
Severe acute malnutrition, Nutritional rehabilitation, F75, Stabilization phase, Therapeutic complex of vitamins and minerals (CMV), Kwashiorkor, Marasmus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be an open, randomized controlled trial aimed at testing the effectiveness of three therapeutic diet regimens during the first phase of hospital management of children with complicated SAM admitted to CREN, Bobo Dioulasso. Children aged 6 to 59 months hospitalized in the pediatric department or other services of the Bobo Dioulassso CHUSS, and admitted to the CREN for complicated SAM (WHZ < -3 SD and/or MUAC < 115 mm and/or the presence of nutritional edema) will be randomly assigned to receive: Standard F75; Alternative F75 without CMV (mainly containing corn flour, sugar, powdered milk and oil); and Alternative F75 with CMV (includes most minerals and vitamins like F75 and F100).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
297 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard F75
Arm Type
Active Comparator
Arm Description
At the admission, therapeutic food is given by the nurses every 2 hours on the first day; then if tolerance is good, every 3 hours the following days. No family meals during the stabilization phase. But the baby can breastfeed. A child will receive an antibiotic as per the national protocol, malaria treatment if diagnosed with malaria, Vitamin A if symptomatic eye damage, Folic acid in case of anemia, antifungal in case of candidiasis.
Arm Title
Alternative F75 with CMV
Arm Type
Experimental
Arm Description
At the admission, therapeutic food is given by the nurses every 2 hours on the first day; then if tolerance is good, every 3 hours the following days. No family meals during the stabilization phase. But the baby can breastfeed. A child will receive an antibiotic as per the national protocol, malaria treatment if diagnosed with malaria, Vitamin A if symptomatic eye damage, Folic acid in case of anemia, antifungal in case of candidiasis.
Arm Title
Alternative F75 without CMV
Arm Type
Experimental
Arm Description
At the admission, therapeutic food is given by the nurses every 2 hours on the first day; then if tolerance is good, every 3 hours the following days. No family meals during the stabilization phase. But the baby can breastfeed. A child will receive an antibiotic as per the national protocol, malaria treatment if diagnosed with malaria, Vitamin A if symptomatic eye damage, Folic acid in case of anemia, antifungal in case of candidiasis.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard F75
Intervention Description
F-75 contains 75 kcal and 0.9 g protein per 100 ml
Intervention Type
Dietary Supplement
Intervention Name(s)
Alternative F75 with CMV
Intervention Description
Alternative F75 With CMV contains cereal flour, oil, sugar, powdered milk with complex mineral-vitamin (CMV)
Intervention Type
Dietary Supplement
Intervention Name(s)
Alternative F75 without CMV
Intervention Description
Alternative F75 without CMV contains cereal flour, oil, sugar, powdered milk without complex mineral vitamin (CMV).
Primary Outcome Measure Information:
Title
Recovery rate of children
Description
Number of children treated and admitted to the transition phase
Time Frame
Three to Five days
Title
Daily weight gain
Description
Average daily weight gain in the stabilization phase in Grams
Time Frame
Three to Five days
Title
Number of days during the first phase of treatment
Description
Average number of days spent in the stabilization phase in Day
Time Frame
Three to Five days
Secondary Outcome Measure Information:
Title
% of intake of the therapeutic regimen
Description
Daily intake of the administered dietary treatment
Time Frame
Three to Five days
Title
Anorexia
Description
Serious severe event that occurs at anytime during the treatment
Time Frame
Three to Five days
Title
Mortality
Description
Serious severe event that occurs at anytime during the treatment
Time Frame
Three to Five days
Title
Diarrhea
Description
Serious severe event that occurs at anytime during the treatment
Time Frame
Three to Five days
Title
Vomiting
Description
Serious severe event that occurs at anytime during the treatment
Time Frame
Three to Five days
Other Pre-specified Outcome Measures:
Title
HIV/AIDS
Description
Detection of HIV/AIDS using polymerase chain reaction (PCR) in infants and children younger than 18 months or retroviral serology test in older children.
Time Frame
Three to Five days
Title
Hepatitis infection
Description
Blood test of hepatitis using the enzyme-linked immunosorbent assay (ELISA)
Time Frame
Three to Five days
Title
Tuberculosis infection
Description
Test of tuberculosis via search for Koch's Bacillus in gastric/spit tubing and molecular testing of stools using polymerase chain reaction (PCR)
Time Frame
Three to Five 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 Weight-for-Height Z-score (WHZ) <- 3 SD AND / OR MUAC <115 mm AND / OR with edema With complications Who are admitted and treated in the refeeding center (CREN) of the CHUSS Aged between 6 and 59 Months Parental Signed informed consent form Exclusion Criteria: Children younger than 6 months or older than 59 months of age Moderate Acute Malnutrition (MAM)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Souheila Abbeddou, MSc. PhD
Phone
+32467630892
Email
Souheila.Abbeddou@UGent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Jerome Some, Md. PhD
Phone
0022660540930
Email
joserweb@yahoo.fr
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimé Kissou, Md.
Email
aimekissou@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Bintou Sanogo, MSc. Md
Phone
0022670001991
Email
bintusan@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Bintou Sanogo, MSc. Md
First Name & Middle Initial & Last Name & Degree
Jerome Some, Md. PhD
First Name & Middle Initial & Last Name & Degree
Aimé Kissou, Md.
First Name & Middle Initial & Last Name & Degree
Souheila Abbeddou, MSc. PhD
First Name & Middle Initial & Last Name & Degree
Stefaan De Henauw, Md. PhD

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
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
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
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
24606092
Citation
Bartz S, Mody A, Hornik C, Bain J, Muehlbauer M, Kiyimba T, Kiboneka E, Stevens R, Bartlett J, St Peter JV, Newgard CB, Freemark M. Severe acute malnutrition in childhood: hormonal and metabolic status at presentation, response to treatment, and predictors of mortality. J Clin Endocrinol Metab. 2014 Jun;99(6):2128-37. doi: 10.1210/jc.2013-4018. Epub 2014 Feb 27.
Results Reference
background
PubMed Identifier
12764489
Citation
Deen JL, Funk M, Guevara VC, Saloojee H, Doe JY, Palmer A, Weber MW. Implementation of WHO guidelines on management of severe malnutrition in hospitals in Africa. Bull World Health Organ. 2003;81(4):237-43. Epub 2003 May 16.
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

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Effectiveness of Alternative Diets During the Stabilization Phase on Children With Complicated SAM

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