Ignite Creation Date:
2024-05-06 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03606993
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2018-07-10
Brief Title:
Iron Fish for Dominican Republic DR Infants
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Cooking With Iron Ingots Assessing Feasibility and Natural History Among Infants in Resource-limited Settings
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Fishor enhanced standard of care
Detailed Description:
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None