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

This study has been completed.
Sponsor:
Collaborator:
H.J Heinz Foundation
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00392418
First received: October 24, 2006
Last updated: March 11, 2010
Last verified: January 2008
  Purpose

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.


Condition Intervention
Anemia
Drug: Multiple micronutrient supplement (iron)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Effectiveness of Flexible Administration of Sprinkles® in a Mixed Population of Anemic and Non-anemic Infants and Young Children in Rural Bangladesh.

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • hemoglobin concentration [ Time Frame: at end of treatment and 6 months post-treatment ] [ Designated as safety issue: No ]
  • adherence measured by the number of sachets used [ Time Frame: end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • morbidity from diarrhea and acute respiratory infections at treatment end and 6 months post treatment

Estimated Enrollment: 360
Study Start Date: May 2004
Estimated Study Completion Date: March 2005
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%%).

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392418

Locations
Bangladesh
Research and Evaluation Division, BRAC
Dhaka, Bangladesh
Sponsors and Collaborators
The Hospital for Sick Children
H.J Heinz Foundation
Investigators
Principal Investigator: Stanley H Zlotkin, PhD The Hospital for Sick Children, Toronto, Canada
  More Information

No publications provided

Responsible Party: Stanley Zlotkin/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00392418     History of Changes
Other Study ID Numbers: 1000005427
Study First Received: October 24, 2006
Last Updated: March 11, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
iron deficiency anemia
hematologic disease
infancy
pediatrics
Sprinkles®
iron
micronutrient

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014