NCT02610881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

4 months

First QC Date

November 18, 2015

Last Update Submit

April 22, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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)

Secondary Outcomes (2)

  • Change in perceived barriers to vitamin supplementation

    Baseline, Endline (Up to 5 months)

  • Preferred method of distribution

    Endline (Up to 5 months)

Study Arms (2)

Iron and Folic Acid (IFA)/Micronutrient Powders (MNP)

EXPERIMENTAL

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)Dietary Supplement: Micronutrient Powders (MNP)Behavioral: Iron Plus Strategy Counseling

Micronutrient Powders (MNP)/Iron and Folic Acid (IFA)

EXPERIMENTAL

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)Dietary Supplement: Micronutrient Powders (MNP)Behavioral: Iron Plus Strategy Counseling

Interventions

Iron and Folic Acid (IFA)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.

Iron and Folic Acid (IFA)/Micronutrient Powders (MNP)Micronutrient Powders (MNP)/Iron and Folic Acid (IFA)
Micronutrient Powders (MNP)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 and Folic Acid (IFA)/Micronutrient Powders (MNP)Micronutrient Powders (MNP)/Iron and Folic Acid (IFA)
Iron Plus Strategy CounselingBEHAVIORAL

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.

Iron and Folic Acid (IFA)/Micronutrient Powders (MNP)Micronutrient Powders (MNP)/Iron and Folic Acid (IFA)

Eligibility Criteria

Age6 Months - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Singleton Children or one child per home

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CARE-India

Patna, Bihar, India

Location

Related Publications (1)

  • Young MF, Girard AW, Mehta R, Srikantiah S, Gosdin L, Menon P, Ramakrishnan U, Martorell R, Avula R. Acceptability of multiple micronutrient powders and iron syrup in Bihar, India. Matern Child Nutr. 2018 Apr;14(2):e12572. doi: 10.1111/mcn.12572. Epub 2017 Dec 6.

    PMID: 29210507DERIVED

MeSH Terms

Conditions

Anemia

Interventions

IronFolic Acid

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Melissa Young, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 20, 2015

Study Start

December 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 25, 2016

Record last verified: 2016-04

Locations

IN(1)