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Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C

The Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores: Determination of a Dose-dependent Effect of Galacto-oligosaccharides on Iron Absorption, With and Without Addition of Ascorbic Acid

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03762148
Acronym
Fe_GOS_2
Enrollment
46
Registered
2018-12-03
Start date
2019-04-01
Completion date
2019-06-11
Last updated
2019-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron-deficiency

Keywords

iron-deficiency, prebiotics, galacto-oligosaccharides

Brief summary

Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. In a recent iron absorption study in adult women with low iron stores in our lab (publication under review), we found that 15 g of GOS given with an iron supplement in the form of iron fumarate acutely increased iron absorption when given with water and a bread based meal. The dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on absorption with other enhancers of iron absorption, such as vitamin c.

Detailed description

Iron is an important mineral in our body and fulfills essential functions such as for example oxygen transport from the lungs to the tissues. Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. Common iron supplements all have their limitations in terms of availability and compatibility. Prebiotic fibers, such as galacto-oligosaccharides (GOS), selectively enhance growth of beneficial colonic bacteria. Prebiotics in general enhance the production of short-chain fatty acids (SCFAs) and thereby decrease luminal pH. Through the reduction in pH, prebiotics can enhance absorption of minerals such as calcium and magnesium and they have been proposed to potentially improve iron absorption. In a recent iron absorption study in adult women with low iron stores in our lab (publication under review), we found that 15 g of GOS given with an iron supplement in the form of iron fumarate acutely increased iron absorption when given with water and a bread based meal. The dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on absorption with other enhancers of iron absorption, such as vitamin c.

Interventions

DIETARY_SUPPLEMENTferrous fumarate

nutritional iron (14 mg) supplement in form of ferrous fumarate

DIETARY_SUPPLEMENTferrous sulphate

nutritional iron (14 mg) supplement in form of ferrous sulphate

DIETARY_SUPPLEMENTferric pyrophosphate

nutritional iron (14 mg) supplement in form of ferric pyrophosphate

DIETARY_SUPPLEMENTferrous fumarate + 3.5 g GOS

nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (3.5 g GOS)

DIETARY_SUPPLEMENTferrous fumarate + 7 g GOS

nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS)

DIETARY_SUPPLEMENTferrous sulphate + 15 g GOS

nutritional iron (14 mg) supplement in form of ferrous sulphate with addition of prebiotics (15 g GOS)

DIETARY_SUPPLEMENTferrous fumarate + Vitamin C

nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of Vitamin C

DIETARY_SUPPLEMENTferric pyrophosphate + 15 g GOS

nutritional iron (14 mg) supplement in form of ferric pyrophosphate with addition of prebiotics (15 g GOS)

DIETARY_SUPPLEMENTferrous fumarate + 7 g GOS + Vitamin C

nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) and Vitamin C

Sponsors

Burgerstein Vitamine
CollaboratorINDUSTRY
Isabelle Herter-Aeberli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Female, 18 to 45 years old * SF levels \<30 µg/L * Normal body Mass Index (18.5-24.9 kg/m2) * Body weight \<70 kg * Signed informed consent

Exclusion criteria

* Severe anaemia (Hb \< 80 g/L) * Elevated CRP \>10.0 mg/L * Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) * Continuous/long-term use of medication during the whole studies (except for contraceptives) * Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, including pre- and-or probiotics supplements (excluding foods and beverages with life cultures such as yoghurt, raw milk cheese and kombucha) * Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months * Difficulties with blood sampling * Use of antibiotics over the past month * Known hypersensitivity to iron supplements in the given amount, GOS, or lactose * Women who are pregnant or breast feeding * Women who intend become pregnant during the course of the study * Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, inject-able, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases * Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse - * Smokers (\> 1 cigarette per week) * Inability to follow the procedures of the study, e.g. due to language problems, self-- reported psychological disorders, etc. of the participant * Enrollment of the investigator, his/her family members, employees and other dependent persons

Design outcomes

Primary

MeasureTime frameDescription
fractional iron absorption2 monthsFractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of several isotopically labelled iron supplements.Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026