Flexible Administration of Sprinkles® in Infants and Young Children in Rural Bangladesh.
Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
Summary
Millions of people worldwide are affected by iron deficiency anemia (IDA). IDA is a
widespread serious public health problem, especially for infants in developing countries
mainly because of inadequate intake of iron due to the poor bioavailability of dietary iron
in predominately cereal based diets. One of the ways to combat iron deficiency anemia is by
supplementation to targeted populations. Although iron drops have been used, they have been
largely unsuccessful in reducing the prevalence of anemia because of compliance, distribution
and supply issues. Sprinkles® are a new approach to iron delivery that is as efficacious as
iron drops and more acceptable. For Sprinkles® to be implemented into nation-wide programs as
a sustainable alternative to current iron supplementation approaches, an optimal model of use
and distribution for Sprinkles® needs to be established. By comparing daily versus flexible
use of Sprinkles® (60 sachets over 60, 90 and 120 days) among infants and young children aged
6-24 months, the primary objectives are to study the effect of the three administration
models of Sprinkles® on changes in:
1. hemoglobin concentration; and
2. compliance or adherence to the intervention.
ii. The secondary objective of this study is to determine the acceptability of each of the
three intervention models.
We hypothesize that adherence will be greater and hemoglobin concentration response will be
higher in those given 'flexible' instructions to use all of the Sprinkles® supplied over a
specific period of time compared to those given strict instructions for daily use.