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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Iron and Folic Acid (IFA)

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type DIETARY_SUPPLEMENT

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

Iron Plus Strategy Counseling

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Iron and Folic Acid (IFA)

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type DIETARY_SUPPLEMENT

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

Iron Plus Strategy Counseling

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No