The Effect of Lactoferrin and Dosing Regimen on Iron Absorption From a Maize-based Porridge in Kenyan Infants
The Effect of Apo- and Holo-Lactoferrin and Dosing Regimen on Iron Absorption From a Maize-based Porridge in Kenyan Infants
1 other identifier
interventional
25
1 country
1
Brief Summary
The purpose of this study is to measure iron absorption from maize-based porridge fortified with either apo-lactoferrin, holo-lactoferrin or ferrous sulfate and to test whether there is an effect of these. Additionally, iron absorption from maize-based porridge containing 12 mg ferrous sulfate will be measured when consumed every other day versus every third day.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedStudy Start
First participant enrolled
December 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedMay 13, 2020
May 1, 2020
4 months
July 24, 2018
May 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Fractional iron absorption (%)
Fractional iron absorption from 3 different test meals (apo-, holo-Lactoferrin and FeSO4) erythrocyte incorporation of stable iron isotopes into red blood cells 14 days after test meal
Day 21
Secondary Outcomes (7)
Fractional iron absorption (%)
Day 41
Hemoglobin in g/dL (in blood)
Baseline, Day 21, Day 24 (after 1 day washout), Day 27 (after 2 days washout), Day 41
Plasma ferritin in µg/L (in blood)
Baseline, Day 21, Day 24 (after 1 day washout), Day 27 (after 2 days washout), Day 41
Soluble transferrin receptor in mg/L (in blood)
Baseline, Day 21, Day 24 (after 1 day washout), Day 27 (after 2 days washout), Day 41
C-reactive protein in mg/L (in blood)
Baseline, Day 21, Day 24 (after 1 day washout), Day 27 (after 2 days washout), Day 41
- +2 more secondary outcomes
Study Arms (6)
apo-Lactoferrin
PLACEBO COMPARATORunsaturated (= no iron) form of Lactoferrin Lactoferrin is a bovine milk protein Test Meal A1
holo-Lactoferrin
PLACEBO COMPARATORsaturated (= contains a certain amount of iron) form of Lactoferrin Lactoferrin is a bovine milk protein Test Meal B1
FeSO4
PLACEBO COMPARATORFerrous sulfate = FeSO4 acting as the reference Test Meal C1
1. FeSO4
PLACEBO COMPARATORFerrous sulfate = FeSO4 Test Meal A2
FeSO4 after 1 day break
PLACEBO COMPARATORFerrous sulfate = FeSO4 Test Meal B2
FeSO4 after 2 day break
PLACEBO COMPARATORFerrous sulfate = FeSO4 Test Meal C2
Interventions
1.41 g of apo-Lactoferrin will be given together with 1.42 mg FeSO4 (0.08 mg of iron naturally in apo-Lf \[total of 1.5 mg iron\]) in a maize porridge (extrinsically labeled)
1.41 g of holo-Lactoferrin (intrinsically labeled with 1.5 mg 57Fe) will be given together in a maize porridge
10 mg 56Fe + 2 mg 57Fe Is the 2. FeSO4 in maize porridge with a 1 day washout period
10 mg 56Fe + 2 mg 58Fe Is the 3. FeSO4 in maize porridge with a 2 day washout period
Eligibility Criteria
You may qualify if:
- Age of 3-14 months at baseline
- Complementary feeding of the infant has already started
- Assessment of good health as assessed by professional staff at Msambweni District Hospital
- The caregiver is willing to participate in the study
- The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy)
- Willingness of the caregiver to provide five blood samples from their child in total during the studies during the visits at the hospital
- Residence in the study for the period of the study
You may not qualify if:
- Hb \<70 g/L
- Severe underweight (waz \<-3)
- Severe wasting (whz \<-3)
- Chronic or acute illness or other conditions that in the opinion of the principle investigator or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- Participants taking part in other studies requiring the drawing of blood
- Regular intake (\>2 days) of iron-containing mineral and vitamin supplements or fortified foods within the last 2 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Msambweni County Referral Hospital
Msambweni, Kwale County, Kenya
Related Publications (2)
Mikulic N, Uyoga MA, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. Iron Absorption is Greater from Apo-Lactoferrin and is Similar Between Holo-Lactoferrin and Ferrous Sulfate: Stable Iron Isotope Studies in Kenyan Infants. J Nutr. 2020 Dec 10;150(12):3200-3207. doi: 10.1093/jn/nxaa226.
PMID: 32886113DERIVEDUyoga MA, Mikulic N, Paganini D, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants. Am J Clin Nutr. 2020 Oct 1;112(4):1132-1141. doi: 10.1093/ajcn/nqaa174.
PMID: 32678434DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Laboratory of Human Nutrition
Study Record Dates
First Submitted
July 24, 2018
First Posted
August 6, 2018
Study Start
December 11, 2018
Primary Completion
March 30, 2019
Study Completion
March 30, 2019
Last Updated
May 13, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share