Iron Absorption From Lipid-Based Nutrient Supplements

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: Healthy; Undernutrition
• Intervention / Treatment: Dietary supplement: Lipid-Based Nutrient Supplement

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Kenya
  • Msambweni, Kenya
    • Msambweni County Referral Hospital

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	Isotope incorporation into RBCs on day 14

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

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): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Nutritional and Metabolic Diseases; Malnutrition
• 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