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

April 14, 2021 updated by: Stanley Zlotkin, The Hospital for Sick Children

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:

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Research and Evaluation Division, BRAC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hemoglobin concentration
Time Frame: at end of treatment and 6 months post-treatment
at end of treatment and 6 months post-treatment
adherence measured by the number of sachets used
Time Frame: end of treatment
end of treatment

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Heinz Endowments

Investigators

  • Principal Investigator: Stanley H Zlotkin, PhD, The Hospital for Sick Children, Toronto, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

March 1, 2005

Study Registration Dates

First Submitted

October 24, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000005427

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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