Severe Acute Malnutrition Clinical Trial
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
Verified date | October 2023 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | August 31, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 59 Months |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - SAM without edema - Moderate acute malnutrition (MAM) - Did not improve during the stabilization phase |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Centre Hospitalier Universitaire Souro | Bobo-Dioulasso | Bobo Dioulasso |
Lead Sponsor | Collaborator |
---|---|
University Ghent | Centre Muraz, Institut de Recherche en Sciences de la Sante, Burkina Faso, University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso) |
Burkina Faso,
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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. — View Citation
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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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Severe adverse event | Any serious severe adverse event ranging from diarrhea, vomiting, anorexia to death | Three to Seven days | |
Secondary | Mean number of days for a complete edema resolving | Number of days for a complete edema resolving among Kwashiorkor children, in Day | Three to Seven days | |
Secondary | Intestinal microbiota | 16S rRNA sequencing of DNA extracts of fecal samples | Three to Seven days | |
Secondary | Presence of acidic stools | Measurement of stool potential Hydrogen (pH) | Three to Seven days | |
Secondary | Soil Helminths | Determination of intestinal parasites using Quantitative Real-Time polymerase chain reaction (qPCR) | Three to Seven days | |
Secondary | Epigenetics | In a subsample of children, DNA methylation is identified using Illumina Array Analysis Platform | Three to Seven days |
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