NCT03606993

Brief Summary

This study evaluates the feasibility of cooking with an iron ingot, Lucky Iron Fish™ (LIF), and evaluate the natural history of hemoglobins and iron status among infants of families using this iron ingot in a population with a high prevalence of iron-deficiency anemia. Participants are mother-infant dyads, and are randomized to one of two arms: Lucky Iron Fish™or enhanced standard of care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

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

July 10, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

August 13, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

1.4 years

First QC Date

July 10, 2018

Last Update Submit

January 30, 2020

Conditions

Iron-deficiencyIron Deficiency Anemia

Keywords

Iron-deficiencyIron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin over time

    Investigators will assess changes in hemoglobin within each study arm and compare hemolgobin levels between study arms (intervention vs. standard of care). Hemoglobin will be measured in grams per deciliter (g/dL) and measured at 6-months, and 12-months. If data is normally distributed, a paired/dependent t-test will be used, if non-normal, a non-parametric test like Wilcoxon's Matched pairs test will be used.

    6-months and 12-months

Secondary Outcomes (5)

  • Rates of refusal

    12-months

  • Retention

    12-months

  • Adherence to iron ingot use

    12-months

  • Difference in microbiomes and microbiota

    12-months

  • Difference in microbiomes and microbiota

    12-months

Study Arms (2)

Lucky Iron Fish™ (LIF)

EXPERIMENTAL

For Mother-infant dyads enrolled into the LIF arm, mother receives a cooking supplement: one \~ 200g iron ingot.

Other: Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement

Enhanced standard of care (eSOC)

NO INTERVENTION

For mother-infant dyads in the eSOC arm, families are not provided iron supplementation (consistent with standard of care) but have additional visits and laboratory monitoring beyond well-child care (enhanced).

Interventions

Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplementOTHER

For Mother-infant dyads enrolled into the LIF arm, mother receives one \~ 200g iron ingot, instructions on use: add 2-3 drops of lemon juice to one-liter of water, place iron ingot in water, bring to boil for 10 minutes, remove iron fish from water and then use that water for cooking or drinking.

Lucky Iron Fish™ (LIF)

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Mother ≥ 18 years of age
  • A newborn delivered at ≥ 35 weeks
  • Infant Child followed by (or will be followed by) affiliated clinic (Niños Primeros en Salud \[NPS\]) OR Infant delivered at Angel Ponce, the local maternity hospital of Consuelo, Dominican Republic.
  • Mother is Spanish speaking
  • Mother permission is provided (informed consent)

You may not qualify if:

  • Maternal history of Sickle Cell Disease (homozygous)
  • Concurrent enrollment in related study of LIF on anemia of young children (CHOP study #16-012631).
  • Inability to understand and speak Spanish
  • Severe cognitive impairment or severe psychiatric disease which would prohibit the answering of study questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ninos Primeros en Salud

Consuelo, San Pedro de Macorís, Dominican Republic

Location

Related Publications (1)

  • McKee SG, Close R, Lowenthal E. Evaluation of Iron Deficiency Anemia in a Pediatric Clinic in the Dominican Republic. Ann Glob Health. 2017 May-Aug;83(3-4):550-556. doi: 10.1016/j.aogh.2017.07.004.

    PMID: 29221528BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Elizabeth Lowenthal, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2018

First Posted

July 31, 2018

Study Start

August 13, 2018

Primary Completion

January 17, 2020

Study Completion

January 17, 2020

Last Updated

January 31, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

DO(1)