Undernutrition, Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLipid-Based Nutrient Supplement
LNS labeled with a stable iron isotope
Sponsors
Jomo Kenyatta University of Agriculture and Technology
Pennington Biomedical Research Center
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dietary iron absorption | Isotope incorporation into RBCs on day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | Measured at screening | Hemoglobin concentration |
| Serum ferritin | Measured at screening | Serum ferritin concentration |
| Soluble transferrin receptor | Measured at screening | Soluble transferrin receptor concentration |
| Transferrin saturation | Measured at screening | Transferrin saturation percentage |
| Hepcidin | Measured at screening | Hepcidin concentration |
| C-reactive protein | Measured at screening | C-reactive protein concentration |
| Alpha-1-acid glycoprotein | Measured at screening | Alpha-1-acid glycoprotein concentration |
Countries
Kenya
Outcome results
None listed