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Completed

NCT Number: NCT03606993

Iron Fish for Dominican Republic (DR) Infants

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ninos Primeros en Salud

Consuelo, San Pedro de Macorís, Dominican Republic

About this study

Iron deficiency and iron-deficiency anemia contribute significantly to global pediatric morbidity, predominantly affecting women and preschool aged children in resource-limited settings. Iron-deficiency in infancy has been linked to neurodevelopmental delay.

Current methods of iron repletion and supplementation have proved inadequate. The Lucky Iron Fish™ is a iron ingot, the size of a small bar of soap, that is made of pure iron. When boiled, it releases bioavailable iron into water, which is then used for food preparation and/or drinking. Participants in the LIF arm are instructed to acidify the water with citrus juice (provided).

All participants are followed at the same intervals to complete questionnaires and study-related labs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Change in hemoglobin over time

    Time frame: 6-months and 12-months

    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.

Secondary outcomes

  1. Rates of refusal

    Time frame: 12-months

    Rates of refusal to participate in study measured as proportion of subjects refusing to enter study compared to total number approached.

  2. Retention

    Time frame: 12-months

    Within each study arm (Iron ingot vs. Oral iron supplementation), will calculate proportion lost to follow-up. Number of subjects lost to follow up divided total number of subjects enrolled at study entry.

  3. Adherence to iron ingot use

    Time frame: 12-months

    Using a questionnaire with several likert-scale questions, we will assess adherence to iron ingot use. Questions include "When was the last time you used the Fish", "how often do you use the fish for meal preparation", "how often do you use the fish to prepare water", "how long do you typically boil the fish". The answer to each question has between 4-5 possible ordinal responses which will be converted into numerical data (1,2,3,4,5) and cumulative scores will be created to assess degree of use/adherence.

  4. Difference in microbiomes and microbiota

    Time frame: 12-months

    Using results from rectal swabs, the study will compare the microbiome and microbiota of infants receiving LIF+citus vs. eSOC

  5. Difference in microbiomes and microbiota

    Time frame: 12-months

    Using results from nasopharyngeal swabs, the study will compare the microbiome and microbiota of infants receiving LIF+citus vs. eSOC

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Lucky Iron Fish

Registry information

Official study title

Cooking With Iron Ingots: Assessing Feasibility and Natural History Among Infants in Resource-limited Settings

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2018
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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