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

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

Interventions

DIETARY_SUPPLEMENT

Standard F100

100 kcal and 3 g protein per 100 ml

DIETARY_SUPPLEMENT

Standard F75 + Plumpynut

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

DIETARY_SUPPLEMENT

Alternative F75 with CMV + Plumpynut

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

DIETARY_SUPPLEMENT

Alternative F75 without CMV + Plumpynut

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

Sponsors & Collaborators

• Institut de Recherche en Sciences de la Sante, Burkina Faso

  collaborator OTHER_GOV

• University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso)

  collaborator UNKNOWN

• Centre Muraz

  collaborator OTHER

• University Ghent

  lead OTHER

Principal Investigators

• Stefaan De Henauw, Md. PhD · University Ghent

• Souheila Abbeddou, MSc. PhD · University Ghent

• Jerome Some, Md. PhD · Institut de Recherche en Sciences de la Sante, Burkina Faso

• Bintou Sanogo, MSc. Md. · Centre Hospitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-15

Primary Completion

2023-08-31

Completion

2023-08-31

Countries

• Burkina Faso

Study Locations