UndernutritionNCT06870201
Iron Absorption From Lipid-Based Nutrient Supplements
An observational study of Undernutrition and Healthy, run by Pennington Biomedical Research Center at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Undernutrition, Healthy
- What is being tested?
- Lipid-Based Nutrient Supplement
- How many people
- 30 participants
- Where
- 1 siteKenya
- Study dates
- 25 Mar 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants will be recruited from Msambweni and the surrounding rural communities in Kwale County, Kenya.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Iron Absorption From Lipid-Based Nutrient Supplements - A Pilot Study
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.
- Conditions
- Undernutrition, Healthy
- Being tested
- Lipid-Based Nutrient Supplement
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid-Based Nutrient SupplementDietary supplement
LNS labeled with a stable iron isotope
| Study group | Role | What they receive |
|---|---|---|
| Apparently Healthy | Not described Receives: Dietary Supplement: Lipid-Based Nutrient Supplement | |
| Undernourished | Not described Receives: Dietary Supplement: Lipid-Based Nutrient Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary iron absorption
Measured: Isotope incorporation into RBCs on day 14
Secondary outcomes (7)
Hemoglobin
Hemoglobin concentration
Measured: Measured at screening
Serum ferritin
Serum ferritin concentration
Measured: Measured at screening
Soluble transferrin receptor
Soluble transferrin receptor concentration
Measured: Measured at screening
Transferrin saturation
Transferrin saturation percentage
Measured: Measured at screening
Hepcidin
Hepcidin concentration
Measured: Measured at screening
C-reactive protein
C-reactive protein concentration
Measured: Measured at screening
Alpha-1-acid glycoprotein
Alpha-1-acid glycoprotein concentration
Measured: Measured at screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start25 Mar 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology
- Responsible party
- Principal investigator, Stephen Hennigar, Pennington Biomedical Research Center
- Investigators
- Stephen Hennigar, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870201
- Sponsor's protocol ID
- JKU/2/4/896B
- Status last verified
- Jul 2026
- First submitted
- 27 Feb 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Iron Absorption From Lipid-Based Nutrient Supplements - A Pilot Study
- ClinicalTrials.gov ID
- NCT06870201
- Acronym / sponsor ID
- JKU/2/4/896B
- Conditions
- Undernutrition, Healthy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apparently Healthy | – | Dietary Supplement: Lipid-Based Nutrient Supplement |
| Undernourished | – | Dietary Supplement: Lipid-Based Nutrient Supplement |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants will be recruited from Msambweni and the surrounding rural communities in Kwale County, Kenya.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipid-Based Nutrient SupplementLNS labeled with a stable iron isotope | Dietary supplement | Apparently Healthy, Undernourished |
Primary outcome
Dietary iron absorption
Time frame: Isotope incorporation into RBCs on day 14
7 secondary outcomes
Hemoglobin
Time frame: Measured at screening
Serum ferritin
Time frame: Measured at screening
Soluble transferrin receptor
Time frame: Measured at screening
Transferrin saturation
Time frame: Measured at screening
Hepcidin
Time frame: Measured at screening
C-reactive protein
Time frame: Measured at screening
Alpha-1-acid glycoprotein
Time frame: Measured at screening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Hennigar, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undernutrition and Healthy, run by Pennington Biomedical Research Center at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary iron absorption (time frame: Isotope incorporation into RBCs on day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.