An interventional study of Multiple micronutrient supplement (iron) in Anemia, sponsored by The Hospital for Sick Children. Completed at 1 site in Bangladesh. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment
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:
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.
Study Design
This study will follow a community-based cluster randomized clinical trial design involving three intervention groups. Total number of villages included in the study will be determined by the availability of the eligible children. In each village, all eligible children will be screened through house-to-house visits. After the screening, all the children will be randomized by village using a table with randomly assorted table into one of three groups:
In all groups, assessments will be done at baseline, at the end of a group's intervention and at 6 months after intervention in each group for follow-up.
The study will take place in Kaligong sub-district in Bangladesh. All villages in Kaligonj sub-district consist of plain agricultural land. Subsistence farming is the major source of livelihood. Rice is the commonly eaten staple mixed with lentil and vegetable curry and occasionally with pieces of fish and meat. Similar to the rest of the plain areas of the country, malnutrition among women and children is widespread, but malaria is extremely uncommon and the prevalence of hookworm is fairly low (less than 2%%).
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 360 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
hemoglobin concentration
Time frame: at end of treatment and 6 months post-treatment
adherence measured by the number of sachets used
Time frame: end of treatment
Acceptability measured through interview with mothers
weaning food practice at treatment end and 6 months post-treatment
length and weight at treatment end and 6 months post-treatment
morbidity from diarrhea and acute respiratory infections at treatment end and 6 months post treatment
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children