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

NCT05015257 | Completed

• 1 other identifier: BC-09443-B
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Edema redevelopment during the transition phase

  Number of children whose edema redeveloped after it has been resolved during the stabilization phase

  Three to Seven days

• Severe adverse event

  Any serious severe adverse event ranging from diarrhea, vomiting, anorexia to death

  Three to Seven days

Secondary Outcomes (5)

• Mean number of days for a complete edema resolving

  Three to Seven days

• Intestinal microbiota

  Three to Seven days

• Presence of acidic stools

  Three to Seven days

• Soil Helminths

  Three to Seven days

• Epigenetics

  Three to Seven days

Study Arms (4)

Standard F100

ACTIVE COMPARATOR

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

Standard F75+Plumpynut

EXPERIMENTAL

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

Alternative F75 with CMV +Plumpynut

EXPERIMENTAL

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 without CMV +Plumpynut

EXPERIMENTAL

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

Interventions

Standard F100 DIETARY_SUPPLEMENT

100 kcal and 3 g protein per 100 ml

Standard F100

Standard F75 + Plumpynut DIETARY_SUPPLEMENT

Standard F75 with ready to-use therapeutic food (Plumpynut)

Standard F75+Plumpynut

Alternative F75 with CMV + Plumpynut DIETARY_SUPPLEMENT

Alternative F75 containing CMV with ready to-use therapeutic food (Plumpynut)

Alternative F75 with CMV +Plumpynut

Alternative F75 without CMV + Plumpynut DIETARY_SUPPLEMENT

Alternative F75 with no CMV with ready to-use therapeutic food (Plumpynut)

Alternative F75 without CMV +Plumpynut

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier Universitaire Souro

Bobo-Dioulasso, Bobo Dioulasso, Burkina Faso

Location

Related Publications (4)

• 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: 1306670 BACKGROUND

• 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: 26587175 BACKGROUND

• 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: 24277964 BACKGROUND

• 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.

  PMID: 23363771 BACKGROUND

Related Links

• World Health Organization (2013) WHO guideline: updates on the management of severe acute malnutrition in infants and children
• Enquête Nutritionnelle Nationale SMART 2016 au Burkina Faso. 2016 ; 47p
• Ministère de la Sante au Burkina Faso. Protocol National : Prise en charge intégrée de la malnutrition aigüe (PCIMA). 2014

MeSH Terms

Conditions

Severe Acute Malnutrition; Kwashiorkor

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic 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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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®.

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 20, 2021
• Study Start: September 15, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)