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

Not Applicable

Completed

• Conditions: Anemia
• Interventions: Dietary Supplement: Iron and Folic Acid (IFA); Dietary Supplement: Micronutrient Powders (MNP); Behavioral: Iron Plus Strategy Counseling

• Registration Number: NCT02610881
• Lead Sponsor: Emory University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Study Start: 2015-12
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Singleton Children or one child per home

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Iron and Folic Acid (IFA)/Micronutrient Powders (MNP)	Iron and Folic Acid (IFA)	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.
Micronutrient Powders (MNP)/Iron and Folic Acid (IFA)	Iron Plus Strategy Counseling	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.
Iron and Folic Acid (IFA)/Micronutrient Powders (MNP)	Iron Plus Strategy Counseling	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.
Iron and Folic Acid (IFA)/Micronutrient Powders (MNP)	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.
Micronutrient Powders (MNP)/Iron and Folic Acid (IFA)	Micronutrient Powders (MNP)	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.
Micronutrient Powders (MNP)/Iron and Folic Acid (IFA)	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of micronutrient powders (MNP)	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.
Preference for vitamin supplementation	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
Acceptability of iron and folic acid (IFA) syrup	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.
Vitamin supplementation compliance	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.

Secondary Outcome Measures

Name	Time	Method
Change in perceived barriers to vitamin supplementation	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.
Preferred method of distribution	Endline (Up to 5 months)	The preferred method of distribution will be discussed with front line workers in focus group discussions.

Trial Locations

Locations (1)

CARE-India; 🇮🇳 Patna, Bihar, India