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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. Identifier: NCT00392418
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : March 15, 2010
Heinz Endowments
Information provided by:
The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Multiple micronutrient supplement (iron) Not Applicable

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%%).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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.
Study Start Date : May 2004
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Primary Outcome Measures :
  1. hemoglobin concentration [ Time Frame: at end of treatment and 6 months post-treatment ]
  2. adherence measured by the number of sachets used [ Time Frame: end of treatment ]

Secondary Outcome Measures :
  1. Acceptability measured through interview with mothers
  2. weaning food practice at treatment end and 6 months post-treatment
  3. length and weight at treatment end and 6 months post-treatment
  4. morbidity from diarrhea and acute respiratory infections at treatment end and 6 months post treatment

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00392418

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Research and Evaluation Division, BRAC
Dhaka, Bangladesh
Sponsors and Collaborators
The Hospital for Sick Children
Heinz Endowments
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Principal Investigator: Stanley H Zlotkin, PhD The Hospital for Sick Children, Toronto, Canada
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Responsible Party: Stanley Zlotkin/Principal Investigator, The Hospital for Sick Children Identifier: NCT00392418    
Other Study ID Numbers: 1000005427
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: March 15, 2010
Last Verified: January 2008
Keywords provided by The Hospital for Sick Children:
iron deficiency anemia
hematologic disease
Additional relevant MeSH terms:
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Hematologic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs