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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610881
• Other study ID #: IRB00081930
• Status: Completed
• Phase: N/A
• First received: November 18, 2015
• Last updated: April 22, 2016
• Start date: December 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: International Food Policy Research InstituteUnited States: Institutional Committee for Ethics and Review of ResearchIndia: The Indian Institute of Health Management Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 23 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	CARE-India	Patna	Bihar

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	International Food Policy Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of iron and folic acid (IFA) syrup	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)	No
Primary	Acceptability of micronutrient powders (MNP)	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)	No
Primary	Preference for vitamin supplementation	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)	No
Primary	Vitamin supplementation compliance	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)	No
Secondary	Change in perceived barriers to vitamin supplementation	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)	No
Secondary	Preferred method of distribution	The preferred method of distribution will be discussed with front line workers in focus group discussions.	Endline (Up to 5 months)	No