NCT05020847

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

August 2, 2021

Last Update Submit

October 27, 2023

Conditions

Severe Acute MalnutritionKwashiorkorNutritional EdemaMarasmus

Keywords

Severe acute malnutritionNutritional rehabilitationF75Stabilization phaseTherapeutic complex of vitamins and minerals (CMV)KwashiorkorMarasmus

Outcome Measures

Primary Outcomes (3)

  • Recovery rate of children

    Number of children treated and admitted to the transition phase

    Three to Five days

  • Daily weight gain

    Average daily weight gain in the stabilization phase in Grams

    Three to Five days

  • Number of days during the first phase of treatment

    Average number of days spent in the stabilization phase in Day

    Three to Five days

Secondary Outcomes (5)

  • % of intake of the therapeutic regimen

    Three to Five days

  • Anorexia

    Three to Five days

  • Mortality

    Three to Five days

  • Diarrhea

    Three to Five days

  • Vomiting

    Three to Five days

Other Outcomes (3)

  • HIV/AIDS

    Three to Five days

  • Hepatitis infection

    Three to Five days

  • Tuberculosis infection

    Three to Five days

Study Arms (3)

Standard F75

ACTIVE COMPARATOR

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.

Dietary Supplement: Standard F75

Alternative F75 with CMV

EXPERIMENTAL

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.

Dietary Supplement: Alternative F75 with CMV

Alternative F75 without CMV

EXPERIMENTAL

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.

Dietary Supplement: Alternative F75 without CMV

Interventions

Standard F75DIETARY_SUPPLEMENT

F-75 contains 75 kcal and 0.9 g protein per 100 ml

Standard F75
Alternative F75 with CMVDIETARY_SUPPLEMENT

Alternative F75 With CMV contains cereal flour, oil, sugar, powdered milk with complex mineral-vitamin (CMV)

Alternative F75 with CMV
Alternative F75 without CMVDIETARY_SUPPLEMENT

Alternative F75 without CMV contains cereal flour, oil, sugar, powdered milk without complex mineral vitamin (CMV).

Alternative F75 without CMV

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Souro

Bobo-Dioulasso, Bobo Dioulasso, Burkina Faso

Location

Related Publications (5)

  • 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.

    PMID: 24277964BACKGROUND

  • 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.

    PMID: 26587175BACKGROUND

  • Gopalan C. Kwashiorkor and marasmus: evolution and distinguishing features. 1968. Natl Med J India. 1992 May-Jun;5(3):145-51. No abstract available.

    PMID: 1306670BACKGROUND

  • 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.

    PMID: 24606092BACKGROUND

  • 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.

    PMID: 12764489BACKGROUND

Related Links

MeSH Terms

Conditions

Severe Acute MalnutritionKwashiorkorProtein-Energy Malnutrition

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic DiseasesProtein DeficiencyDeficiency Diseases

Study Officials

  • Stefaan De Henauw, Md. PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

  • Souheila Abbeddou, MSc. PhD

    University 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.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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: 1. Standard F75; 2. Alternative F75 without CMV (mainly containing corn flour, sugar, powdered milk and oil); and 3. Alternative F75 with CMV (includes most minerals and vitamins like F75 and F100).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 25, 2021

Study Start

September 15, 2021

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

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

Locations

BU(1)