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Active, Not Recruiting

NCT Number: NCT06870201

Iron Absorption From Lipid-Based Nutrient Supplements

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Undernutrition Healthy Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Msambweni County Referral Hospital

Msambweni, Kenya

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lipid-Based Nutrient Supplement

Dietary Supplement

LNS labeled with a stable iron isotope

Primary outcomes

  1. Dietary iron absorption

    Time frame: Isotope incorporation into RBCs on day 14

Secondary outcomes

  1. Hemoglobin

    Time frame: Measured at screening

    Hemoglobin concentration

  2. Serum ferritin

    Time frame: Measured at screening

    Serum ferritin concentration

  3. Soluble transferrin receptor

    Time frame: Measured at screening

    Soluble transferrin receptor concentration

  4. Transferrin saturation

    Time frame: Measured at screening

    Transferrin saturation percentage

  5. Hepcidin

    Time frame: Measured at screening

    Hepcidin concentration

  6. C-reactive protein

    Time frame: Measured at screening

    C-reactive protein concentration

  7. Alpha-1-acid glycoprotein

    Time frame: Measured at screening

    Alpha-1-acid glycoprotein concentration

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Jomo Kenyatta University of Agriculture and Technology

Registry information

Official study title

Dietary Iron Absorption From Lipid-Based Nutrient Supplements - A Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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