Acceptability and Feasibility of Micronutrient Powders Versus Iron Syrup for Anemia Prevention in Young Children

April 22, 2016 updated by: Melissa Fox Young, Emory University
This study seeks to assess the acceptability, compliance, and preference for iron supplementation; micronutrient powders (MNP) versus iron syrup. Additionally, this study seeks to assess front line health worker perceptions and experiences regarding ease of implementation of each strategy and delivery strategy preference.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The specific aims of this study are to assess the acceptability of, compliance, and preference for two delivery vehicles for pediatric prophylaxis iron supplementation (micronutrient powders (MNP) that contain iron versus iron syrup) among rural households in Bihar India delivered through home visits by front line health workers. Additionally, this study seeks to assess front line health worker perceptions and experiences regarding ease of implementation of each strategy and delivery strategy preference.

Study Type

Interventional

Enrollment (Actual)

110

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

  • India
    • Bihar
      • Patna, Bihar, India
        • CARE-India

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 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Singleton Children or one child per home

Exclusion Criteria:

  • Currently taking iron supplements
  • Mid upper arm circumference (MUAC) or less than 11.5 cm
  • Suspected severe anemia
  • Known case of haemoglobinopathy
  • History of repeated blood transfusion
  • Current pneumonia
  • Current fever
  • Acute diarrhea

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron and Folic Acid (IFA)/Micronutrient Powders (MNP)
Participants will receive iron and folic acid (IFA) drops for one month followed by a two week washout period. Participants will then receive micronutrient powders (MNP) for one month. Mothers of participants will receive counseling on the benefits of iron intake, side effects of IFA, and preservation of IFA bottles and MNP sachets.
Dietary supplement: Iron and Folic Acid (IFA)
1 mg of IFA syrup (containing 20 mg of elemental iron and 100 mcg of folic acid) will be taken twice per week for one month.
Dietary supplement: Micronutrient Powders (MNP)

One sachet of micronutrient powder will be mixed into food to be taken once daily for a total of one month. One sachet of micronutrient powders includes the following:

Iron (Ferrous Fumarate) 12.5 mg Zinc (Zinc Gluconate) 5 mg Folic Acid 0.160 mg Vitamin-A (Vit-A Acetate) 0.30mg Vitamin-C (Ascorbic Acid) 30 mg Vitamin-B12 0.9 mcg Iodine 90 mcg Maltodextrin Base

Behavioral: Iron Plus Strategy Counseling
Mothers of participants will receive counseling on the benefits of regular iron intake, side effects associated with IFA administration, and the preservation of the IFA bottle and MNP sachets.
Experimental: Micronutrient Powders (MNP)/Iron and Folic Acid (IFA)
Participants will receive micronutrient powders (MNP) for one month followed by a two week washout period. Participants will then receive iron and folic acid (IFA) drops for one month. Mothers of participants will receive counseling on the benefits of iron intake, side effects of IFA, and preservation of IFA bottles and MNP sachets.
Dietary supplement: Iron and Folic Acid (IFA)
1 mg of IFA syrup (containing 20 mg of elemental iron and 100 mcg of folic acid) will be taken twice per week for one month.
Dietary supplement: Micronutrient Powders (MNP)

One sachet of micronutrient powder will be mixed into food to be taken once daily for a total of one month. One sachet of micronutrient powders includes the following:

Iron (Ferrous Fumarate) 12.5 mg Zinc (Zinc Gluconate) 5 mg Folic Acid 0.160 mg Vitamin-A (Vit-A Acetate) 0.30mg Vitamin-C (Ascorbic Acid) 30 mg Vitamin-B12 0.9 mcg Iodine 90 mcg Maltodextrin Base

Behavioral: Iron Plus Strategy Counseling
Mothers of participants will receive counseling on the benefits of regular iron intake, side effects associated with IFA administration, and the preservation of the IFA bottle and MNP sachets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of iron and folic acid (IFA) syrup
Time Frame: Endline (Up to 5 months)
Caregiver change in acceptability of iron and folic acid (IFA) syrup will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitudes towards usage.
Endline (Up to 5 months)
Acceptability of micronutrient powders (MNP)
Time Frame: Endline (Up to 5 months)
Caregiver change in acceptability of micronutrient powders (MNP) will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitudes towards usage.
Endline (Up to 5 months)
Preference for vitamin supplementation
Time Frame: Endline (Up to 5 months)
Caregiver change in preference for vitamin supplementation (IFA versus MNP) will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitu
Endline (Up to 5 months)
Vitamin supplementation compliance
Time Frame: Baseline, Endline (Up to 5 months)
Caregiver change in vitamin supplementation compliance will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitudes towards usage.
Baseline, Endline (Up to 5 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in perceived barriers to vitamin supplementation
Time Frame: Baseline, Endline (Up to 5 months)
Caregiver change in perceived barriers to vitamin supplementation will be assessed using the Relative Preference, Acceptability, and Compliance of Iron Syrup versus Multiple Micronutrient Powders (MMP) Among Infants 6-23 Months in Bihar, India survey. This survey collects information regarding the use of iron and nutrient supplementation, barriers to usage, and attitudes towards usage.
Baseline, Endline (Up to 5 months)
Preferred method of distribution
Time Frame: Endline (Up to 5 months)
The preferred method of distribution will be discussed with front line workers in focus group discussions.
Endline (Up to 5 months)

Collaborators and Investigators

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

Sponsor

Emory University

Collaborators

International Food Policy Research Institute

Investigators

  • Principal Investigator: Melissa Young, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

April 25, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00081930

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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