Iron Absorption From Lipid-Based Nutrient Supplements

Pennington Biomedical Research Center

Status

Active, not recruiting

Conditions

Healthy

Undernutrition

Treatments

Dietary Supplement: Lipid-Based Nutrient Supplement

Study type

Observational

Funder types

Other

Identifiers

NCT06870201

JKU/2/4/896B

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

1 to 3 years old

Volunteers

Accepts Healthy Volunteers

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