Iron Fish in Dominican Republic (DR) Children

NCT03199235 | Completed DMC

• 1 other identifier: 16-012631
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to assess the acceptability, feasibility, and barriers to Lucky Iron Fish™ (LIF) utilization among families with young children in a Latin American community with a high prevalence of iron deficiency and iron-deficiency anemia. .

Conditions

Iron Deficiency Anemia; Anemia; Iron-deficiency

Keywords

iron intake; iron bioavailability

Outcome Measures

Primary Outcomes (7)

• Rates of refusal

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

  12-months

• Retention

  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.

  12-months

• Adherence to iron ingot use

  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.

  12-months

• Adherence to oral iron use

  Using a questionnaire with several likert-scale questions, we will assess adherence to oral iron supplementation. Questions include: "How many doses were missed each week", "Do you recall dose and frequency of oral iron you were prescribed", "If doses were missed, was this accidental, intentional, or both". 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.

  12-months

• Natural history of hemoglobin among those subjects using iron ingot

  We will assess changes in hemoglobin WITHIN iron ingot study arm. Hemoglobin will be measured in grams per deciliter (g/dL) and measured at enrollment, 3-months, 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.

  Will be at 4 individual points over a 12-mo period - at enrollment, 3-month follow-up, 6-month follow-up, and 12-month follow-up which is study end. Thus, the time frame is 4 separate visits over a 12-month period

• Natural history of hemoglobin among those subjects using oral iron

  We will assess changes in hemoglobin WITHIN oral iron study arm. Hemoglobin will be measured in grams per deciliter (g/dL) and measured at enrollment, 3-months, 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.

  Will be at 4 individual points over a 12-mo period - at enrollment, 3-month follow-up, 6-month follow-up, and 12-month follow-up which is study end. Thus, the time frame is 4 separate visits over a 12-month period

• Natural history hemoglobin: Iron ingot vs. Oral iron

  The difference in change in hemoglobin (measure in g/dL) between the study study arms (iron ingot arm vs. oral iron supplementation arm) will be assessed using two-sample t-test (normal distribution) or Wilcoxon-rank-sum (non-normal distribution).

  12-month.

Secondary Outcomes (3)

• Natural history of serum ferritin among subjects using iron ingot

  Will be at 4 individual points over a 12-mo period - at enrollment, 3-month follow-up, 6-month follow-up, and 12-month follow-up which is study end. Thus, the time frame is 4 separate visits over a 12-month period

• Natural history of serum ferritin among subjects using oral iron

  Will be at 4 individual points over a 12-mo period - at enrollment, 3-month follow-up, 6-month follow-up, and 12-month follow-up which is study end. Thus, the time frame is 4 separate visits over a 12-month period

• Natural history serum ferritin: Iron ingot vs. Oral iron

  12-months

Study Arms (2)

LIF + Citrus

EXPERIMENTAL

Parents of subjects \> 1 year and \< 5 years with anemia (Hemoglobin \< 11.0 g/dL) are provided the lucky iron fish and citrus along with instructions for use. Followed at regular intervals.

Device: Lucky Iron Fish

enhanced standard of care

ACTIVE COMPARATOR

Parents of subjects \> 1 year and \< 5 years with anemia (Hemoglobin \< 11.0 g/dL) are provided the oral iron supplementation consistent with standard of care, and then followed at regular intervals in addition to any care determined to be necessary by regular provider.

Other: enhanced standard of care

Interventions

Lucky Iron Fish DEVICE

200g iron ingot that is placed in boiling water for 10+ minutes, and then removed. The water is then used to eating and drinking.

LIF + Citrus

enhanced standard of care OTHER

parents of subjects are provided oral iron supplementation per usual clinical care at clinic and followed for their anemia in addition to study visits

enhanced standard of care

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent/guardian ≥ 18 years of age
• Child \> 1 year and \< 5 years of age
• Child followed by Niños Primeros en Salud (NPS)
• Parent/guardian is Spanish speaking
• Parental/guardian permission is provided (informed consent)

You may not qualify if:

• Mother/Infant pairs enrolled in related protocol of this study
• Inability to understand and speak Spanish
• Severe cognitive impairment or severe psychiatric disease which would prohibit the answering of study questions
• Child followed by NPS malnutrition program
• Persons receiving pre-designed nutrient-fortified foods or participation in another nutrition program
• Child has documented sickle cell disease

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Lucky Iron Fish: collaborator

Study Sites (1)

Ninos Primeros en Salud

Consuelo, San Pedro de Macorís, Dominican Republic

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 26, 2017
• Study Start: February 20, 2017
• Primary Completion: October 16, 2018
• Study Completion: October 16, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

DO (1)