The Effect of Lactoferrin and Dosing Regimen on Iron Absorption From a Maize-based Porridge in Kenyan Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-11

Study Completion Date

2019-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Human Milk Oligosaccharides and Galacto-oligosaccharides on Iron Absorption in Kenyan Infants

NCT04163406

Anemia, Iron-deficiency

COMPLETED NA

Effect of Timing of Micronutrient Powder Consumption on Iron Absorption in Infants

NCT02989311

Anemia Iron Deficiency

COMPLETED NA

Iron Absorption From a Wheat-based Instant Cereal:Gut and Stable Isotope Studies in Kenyan Infants

NCT03894358

Iron Absorption Gut Microbiota

COMPLETED NA

Iron Absorption From a Micronutrient Powder Containing Galacto-oligosaccharides (GOS)

NCT02666417

Anemia, Iron-Deficiency

COMPLETED NA

Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya

NCT07315295

Iron Absorption Iron Deficiencies Severly Acutely Malnourished Children +2 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA by ensuring that the iron needs of infants and young children are met without changing their traditional diet. Oral iron syrups, typically containing iron as ferrous sulfate, can also be given to prevent/correct IDA. However, iron absorption from MNPs and iron syrups, particularly when given with complementary foods high in inhibitors of iron absorption, is low. Thus, there is a need to find iron formulations with higher bioavailability for use in African infants. In a recent trial in Kenya, the investigators demonstrated that a prebiotic could improve iron bioavailability from an iron-containing MNP.

In this study, the investigators plan to assess the human milk compound lactoferrin (Lf) as a possible enhancer of iron absorption. Lf is an important iron-binding protein in human milk, which has been thought to be responsible for the high bioavailability of breast-milk iron. It has many biological functions, including iron absorption, antimicrobial activity, immunomodulatory effects and stimulatory effect on cell proliferation. Lf has different iron binding statuses: the iron free form (apo-Lf) and the iron-saturated form (holo-Lf). One of the two main biological activities of Lf provided by the diet is the control of iron uptake, which is mediated by the Lf receptor (LFR) as undigested Lf can bind to LFR and facilitate the uptake of iron. Therefore, Lf may be a nutritional iron source and may enhance iron absorption in infants. To evaluate the possible role of Lf on the availability of iron, iron absorption will be measured from bovine Lf (bLf). BLf has GRAS (generally considered as safe) status by the US Food and Drug Administration.

To optimize iron absorption, timing of supplementation might as well be important. Hepcidin, a key regulator of systemic iron balance and a single dose of iron can increase hepcidin levels and potentially inhibit iron absorption from a second dose, consumed close in time to the first dose. The investigators will conduct two studies, where 24 infants aged 3-14 months in Msambweni, Kenya, will be enrolled. In study 1, on three alternate mornings, these infants will consume maize porridge containing a low iron dose (1.5 mg) to compare iron absorption between meals with apo-Lf, holo-Lf and ferrous sulfate (FeSO4) as a reference; and whether the addition of either apo- or holo-Lf has a beneficial effect on iron absorption. The investigators hypothesize that iron absorption will be higher when holo-Lf is present in the meal compared to apo-Lf. In study 2, the investigators want to compare two different dosing regimens, in which they measure iron absorption after one-day washout period and after a two-day washout period, and hypothesize that absorption will be higher after 2 days of washout.

The data from this project will provide valuable information towards the development of new, highly bioavailable iron formulations and dosing regimen that is most efficient.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron-deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.