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

NCT00392418 | Completed

• 1 other identifier: 1000005427
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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. 1.hemoglobin concentration; and
2. 2.compliance or adherence to the intervention.

Conditions

Anemia

Keywords

iron deficiency anemia; hematologic disease; infancy; pediatrics; Sprinkles®; iron; micronutrient

Outcome Measures

Primary Outcomes (2)

• hemoglobin concentration

  at end of treatment and 6 months post-treatment

• adherence measured by the number of sachets used

  end of treatment

Secondary Outcomes (4)

• 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

Interventions

Multiple micronutrient supplement (iron) DRUG

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Severe anemia (hemoglobin concentration \<70 g/L).

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Heinz Endowments: collaborator

Study Sites (1)

Research and Evaluation Division, BRAC

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency; Hematologic Diseases

Interventions

Iron

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Stanley H Zlotkin, PhD

  The Hospital for Sick Children, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Global Child Health

Study Record Dates

• First Submitted: October 24, 2006
• First Posted: October 26, 2006
• Study Start: May 1, 2004
• Study Completion: March 1, 2005
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

BA (1)