Flexible Administration of Sprinkles® in Infants and Young Children in Rural Bangladesh.
|First Received Date ICMJE||October 24, 2006|
|Last Updated Date||March 11, 2010|
|Start Date ICMJE||May 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00392418 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Flexible Administration of Sprinkles® in Infants and Young Children in Rural Bangladesh.|
|Official Title ICMJE||The Effectiveness of Flexible Administration of Sprinkles® in a Mixed Population of Anemic and Non-anemic Infants and Young Children in Rural Bangladesh.|
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.
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%%).
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Multiple micronutrient supplement (iron)|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||6 Months to 24 Months|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Bangladesh|
|NCT Number ICMJE||NCT00392418|
|Other Study ID Numbers ICMJE||1000005427|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Stanley Zlotkin/Principal Investigator, The Hospital for Sick Children|
|Study Sponsor ICMJE||The Hospital for Sick Children|
|Collaborators ICMJE||H.J Heinz Foundation|
|Information Provided By||The Hospital for Sick Children|
|Verification Date||January 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP