NCT05015257

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

Completed NA Last updated 3 October 2023

What this trial tests

NA trial testing Standard F100 in Severe Acute Malnutrition in 32 participants. Completed in 31 August 2023.

Timeline

15 September 2021

Primary endpoint
31 August 2023

31 August 2023

Quick facts

Lead sponsor	University Ghent
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	15 September 2021
Primary completion	31 August 2023
Estimated completion	31 August 2023
Sites	1 location across Burkina Faso

Drugs / interventions tested

• Standard F100
• Standard F75 + Plumpynut
• Alternative F75 with CMV + Plumpynut
• Alternative F75 without CMV + Plumpynut

Conditions studied

• Severe Acute Malnutrition — all drugs for Severe Acute Malnutrition →
• Kwashiorkor — all drugs for Kwashiorkor →
• Nutritional Edema — all drugs for Nutritional Edema →

Sponsor

University Ghent

Who can join

Adults 6 Months to 59 Months, any sex, with Severe Acute Malnutrition or Kwashiorkor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.