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Flexible Administration of Sprinkles® in Infants and Young Children in Rural Bangladesh.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392418
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : March 15, 2010
Sponsor:
Collaborator:
Heinz Endowments
Information provided by:
The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE October 24, 2006
First Posted Date  ICMJE October 26, 2006
Last Update Posted Date March 15, 2010
Study Start Date  ICMJE May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2010)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
  • hemoglobin concentration at end of treatment and 6 months post-treatment
  • adherence measured by the number of sachets used at end of treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.
Brief 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.

Detailed Description

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:

  • Daily use of 60 Sprinkles® sachets over 60 days.
  • Flexible use of 60 Sprinkles® sachets over 90 days.
  • Flexible use of 60 Sprinkles® sachets over 120 days.

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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE Drug: Multiple micronutrient supplement (iron)
Study Arms  ICMJE 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 Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 25, 2006)
360
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 6-24 months.
  • Hemoglobin concentration > =70 g/L.
  • Consuming at least one regular meal of complementary food per day.
  • Reportedly free from any acute or chronic illness.
  • Permanent resident of the village.
  • Not receiving any other form of iron supplementation.
  • Parental consent obtained.

Exclusion Criteria:

  • Severe anemia (hemoglobin concentration <70 g/L).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00392418
Other Study ID Numbers  ICMJE 1000005427
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stanley Zlotkin/Principal Investigator, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Heinz Endowments
Investigators  ICMJE
Principal Investigator: Stanley H Zlotkin, PhD The Hospital for Sick Children, Toronto, Canada
PRS Account 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