Iron Absorption From Lipid-Based Nutrient Supplements

NCT06870201 | Active Not Recruiting

• 1 other identifier: JKU/2/4/896B
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Undernutrition; Healthy

Outcome Measures

Primary Outcomes (1)

• Dietary iron absorption

  Isotope incorporation into RBCs on day 14

Secondary Outcomes (7)

• Hemoglobin

  Measured at screening

• Serum ferritin

  Measured at screening

• Soluble transferrin receptor

  Measured at screening

• Transferrin saturation

  Measured at screening

• Hepcidin

  Measured at screening

Study Arms (2)

Apparently Healthy

Dietary Supplement: Lipid-Based Nutrient Supplement

Undernourished

Dietary Supplement: Lipid-Based Nutrient Supplement

Interventions

Lipid-Based Nutrient Supplement DIETARY_SUPPLEMENT

LNS labeled with a stable iron isotope

Apparently Healthy; Undernourished

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Jomo Kenyatta University of Agriculture and Technology: collaborator

Study Sites (1)

Msambweni County Referral Hospital

Msambweni, Kenya

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Stephen Hennigar, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 11, 2025
• Study Start: March 25, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)