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

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.

Conditions

• Severe Acute Malnutrition
• Kwashiorkor
• Nutritional Edema
• Marasmus

Interventions

DIETARY_SUPPLEMENT

Standard F75

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

DIETARY_SUPPLEMENT

Alternative F75 with CMV

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

DIETARY_SUPPLEMENT

Alternative F75 without CMV

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

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