Iron Absorption From Lipid-Based Nutrient Supplements

Active, not recruiting

• Conditions: Undernutrition; Healthy

• Registration Number: NCT06870201
• Lead Sponsor: Pennington Biomedical Research Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-11
• Study Start: 2025-03-25
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Primary Completion: 2025-08-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dietary iron absorption	Isotope incorporation into RBCs on day 14

Secondary Outcome Measures

Name	Time	Method
Hemoglobin	Measured at screening	Hemoglobin concentration
Serum ferritin	Measured at screening	Serum ferritin concentration
Hepcidin	Measured at screening	Hepcidin concentration
Soluble transferrin receptor	Measured at screening	Soluble transferrin receptor concentration
Transferrin saturation	Measured at screening	Transferrin saturation percentage
C-reactive protein	Measured at screening	C-reactive protein concentration
Alpha-1-acid glycoprotein	Measured at screening	Alpha-1-acid glycoprotein concentration

Trial Locations

Locations (1)

Msambweni County Referral Hospital; 🇰🇪 Msambweni, Kenya