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Completed

NCT Number: NCT00392418

Flexible Administration of Sprinkles® in 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.

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Key information

Conditions

Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research and Evaluation Division, BRAC

Dhaka, Bangladesh

About this study

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%%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Multiple micronutrient supplement (iron)

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Heinz Endowments

Registry information

Official study title

The Effectiveness of Flexible Administration of Sprinkles® in a Mixed Population of Anemic and Non-anemic Infants and Young Children in Rural Bangladesh.

Important dates

Study start
2004
Study completion
2005
First posted
Oct 26, 2006
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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