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

Description

Severe acute malnutrition (SAM) is a life threatening condition that requires urgent attention and appropriate management to reduce mortality and promote recovery among children. SAM is defined by 1) a weight-for-height Z-score more than three standard deviations (SD) below the median based on the 2006 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 (SAM with edema) is one of the forms of complicated SAM commonly distinguished by the unmistakable presence of bipedal edema. Kwashiorkor is characterized by the following clinical signs: 1) edemas symmetrical, painless, soft, bilateral, ascending, pitting; 2) lesions of the skin and integuments; 3) ulcerations and depigmentation; 4) alopecia; 5) constant weight loss marked by edema; 6) hepatomegaly; 7) clinical anemia; 8) intestinal transit disorders: persistent diarrhea, vomiting; 9) anorexia and behavioral disorders (apathy).

Severe acute malnutrition 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.

The objective of this study is to determine whether the use of different transition phase diets affect oedema resolving in Kwashiorkor children and to investigate the underlying factors for the relapse or non-responsiveness to the therapeutic treatment.

Hypotheses to be tested

• The first hypothesis is that RUTF (Plumpy-Nut) because of its content in iron may compromise the effectiveness of the transition phase in children with kwashiorkor
• The second hypothesis is that underlying factors including co-morbidities and epigenetics may explain a difference in response to therapeutic regimens

This is an open label randomized controlled trial to test the effectiveness of four used transition phase diets in Kwashiorkor children in their transition to the rehabilitation phase. The four dietary regimens that will be tested are:

1. F100;
2. RUTF+F75;
3. RUTF+alternative F75 with complex mineral-vitamin (CMV); and
4. RUTF+alternative F75 without CMV.

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.

Details