High/Low Dose Vit A in Diarrhea/ALRI in Severe PEM
Status:
Completed
Trial end date:
2007-12-31
Target enrollment:
Participant gender:
Summary
Vitamin A deficiency is an important health problem globally including Bangladesh. The
problem is greater among under-five children, particularly in malnourished. Vitamin A
supplementation reduces morbidity from diarrhoeal diseases and also prevents future diarrhoea
episodes. However, there are conflicting reports on the role of vitamin A supplementation on
morbidity from acute lower respiratory infections (ALRI) including pneumonia. In
non-malnourished children supplementation has been reported to be associated with increased
incidence and morbidity of ALRI. The WHO committee[1] has reviewed both the risk and benefit
of mega dose (200,000 IU) vitamin A supplementation during acute illness particularly
diarrhoea, irrespective of the nutritional status of under-5 children and recommended vitamin
A supplementation in areas where vitamin A status is low. In Bangladesh mega dose (200,000
IU) of vitamin A is routinely supplemented to under-5 children every 6 months. Absorption of
vitamin A precursors from the GI tract is reduced in severely malnourished children, who are
also lacking in retinol binding protein (RBP), required for transportation of retinol to
target tissues. Thus it is established that a significant portion of the supplemented vitamin
A is excreted in feces and urine of malnourished children. The excretion of vitamin A
increases substantially during acute infections including diarrhoeal diseases. On the other
hand, due to reduced RBP, concentration of free vitamin A increases in the body resulting in
the possibility of adverse events including "pseudotumor cerebri". It has recently been
observed that low-dose daily supplementation of vitamin A to malnourished children produces a
better effect on recovery from acute illness and also in preventing infectious diseases among
under-five children. However, the limitations of those studies included a small sample size,
delayed assessment of retinol after supplementation among the others. Thus WHO felt that the
issue needs to be addressed in a well-designed clinical trial. We hope that our proposed
study will enable us to compare the efficacy of low-dose daily administration of vitamin A
with that of initial mega dose followed by daily low dose of vitamin A in malnourished
children presenting with acute diarrhoeal diseases with or without ALRI. If the results of
this study indicate that the daily low-dose has similar efficacy to that of the currently
recommended mega dose followed by daily low-dose of vitamin A, would have important
programmatic implications.
Phase:
N/A
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh