Iron Absorption From Lipid-Based Nutrient Supplements

July 30, 2026 updated by: Stephen Hennigar, Pennington Biomedical Research Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Msambweni, Kenya
        • Msambweni County Referral Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants will be recruited from Msambweni and the surrounding rural communities in Kwale County, Kenya.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Apparently Healthy
Dietary supplement: Lipid-Based Nutrient Supplement
LNS labeled with a stable iron isotope
Undernourished
Dietary supplement: Lipid-Based Nutrient Supplement
LNS labeled with a stable iron isotope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dietary iron absorption
Time Frame: Isotope incorporation into RBCs on day 14
Isotope incorporation into RBCs on day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin
Time Frame: Measured at screening
Hemoglobin concentration
Measured at screening
Serum ferritin
Time Frame: Measured at screening
Serum ferritin concentration
Measured at screening
Soluble transferrin receptor
Time Frame: Measured at screening
Soluble transferrin receptor concentration
Measured at screening
Transferrin saturation
Time Frame: Measured at screening
Transferrin saturation percentage
Measured at screening
Hepcidin
Time Frame: Measured at screening
Hepcidin concentration
Measured at screening
C-reactive protein
Time Frame: Measured at screening
C-reactive protein concentration
Measured at screening
Alpha-1-acid glycoprotein
Time Frame: Measured at screening
Alpha-1-acid glycoprotein concentration
Measured at screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

Jomo Kenyatta University of Agriculture and Technology

Investigators

  • Principal Investigator: Stephen Hennigar, PhD, Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JKU/2/4/896B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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