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Iron Absorption From Lipid-Based Nutrient Supplements | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

Iron Absorption From Lipid-Based Nutrient Supplements

Dietary Iron Absorption From Lipid-Based Nutrient Supplements - A Pilot Study

NCT06870201•Pennington Biomedical Research Center

Summary

The overall objective of this study is to determine dietary iron absorption from lipid-based nutrient supplements (LNS) in apparently healthy and undernourished children. This case-control study will recruit apparently healthy children and children with uncomplicated undernutrition (age 1-3 years, n=15/group) from Msambweni and the surrounding rural communities in Kwale County, Kenya. At the baseline visit (day 0), participants will be provided with an LNS labeled with a stable iron isotope (57-Fe). Participants will return to the hospital 14 days later (day 14) for a blood draw. Blood collected on day 14 will be used to measure iron isotope incorporation into red blood cells. Blood collected at screening will be used to measure indicators of anemia, iron status, hepcidin, and inflammation.

Eligibility

Age

1 - 3 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Children age 1-3 years on day of screening visit
•Hemoglobin 8-11 g/dL on day of screening visit
•Undernourished \[length/height-for-age z-score (HAZ), weight-for-age z-score (WAZ), and/or weight-for-height/length z-score (WHZ) \< -2\] OR apparently healthy (HAZ, WAZ, and/or WHZ ≥ -1)

Exclusion Criteria

•Severe acute malnutrition (WHZ \< -3) with no appetite
•Serious medical condition or other chronic disease besides undernutrition (e.g., HIV+, severe pneumonia, malaria)
•Peanut allergy or other allergy that prevents consumption of the LNS
•Plans to move away from the study location during the study period

Locations (1)

Msambweni County Referral Hospital

Msambweni, Kenya

Key Dates

Start Date

March 25, 2025

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

December 5, 2025

Enrollment

ESTIMATED participants

Conditions

UndernutritionHealthy

Interventions

Lipid-Based Nutrient Supplement

DIETARY_SUPPLEMENT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Iron Absorption From Lipid-Based Nutrient Supplements

Inclusion Criteria

Exclusion Criteria

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