Iron Absorption From Lipid-Based Nutrient Supplements (NCT06870201) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Iron Absorption From Lipid-Based Nutrient Supplements
Kenya30 participantsStarted 2025-03-25
Plain-language 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.
Who can participate
Age range
1 Year – 3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dietary iron absorption
Timeframe: Isotope incorporation into RBCs on day 14