CClinicalTrials.gg
CompletedNCT03762148Fe_GOS_2Updated Jul 25, 2019

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

An interventional study of ferrous fumarate and ferrous sulphate in Iron-deficiency, sponsored by Isabelle Herter-Aeberli. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-07-25.

Sponsored by Isabelle Herter-Aeberli · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Iron-deficiency

Keywords

  • iron-deficiency
  • prebiotics
  • galacto-oligosaccharides
03

In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

This study's enrollment of 46 is below the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Isabelle Herter-Aeberli is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    ferrous fumarate

    labelled iron as ferrous fumarate

    Dietary Supplement: ferrous fumarate

  • Experimental
    ferrous sulphate

    labelled iron as ferrous sulphate

    Dietary Supplement: ferrous sulphate

  • Experimental
    ferric pyrophosphate

    labelled iron as ferric pyrophosphate

    Dietary Supplement: ferric pyrophosphate

  • Experimental
    ferrous fumarate + 3.5 g GOS

    labelled iron as ferrous fumarate + prebiotics in the form of 3.5 g GOS

    Dietary Supplement: ferrous fumarate + 3.5 g GOS

  • Experimental
    ferrous fumarate + 7 g GOS

    labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS

    Dietary Supplement: ferrous fumarate + 7 g GOS

  • Experimental
    ferrous sulphate + 15 g GOS

    labelled iron as ferrous sulphate + prebiotics in the form of 15 g GOS

    Dietary Supplement: ferrous sulphate + 15 g GOS

  • Experimental
    ferrous fumarate + Vitamin C

    labelled iron as ferrous fumarate + Vitamin C

    Dietary Supplement: ferrous fumarate + Vitamin C

  • Experimental
    ferric pyrophosphate + 15 g GOS

    labelled iron as ferric pyrophosphate + prebiotics in the form of 15 g GOS

    Dietary Supplement: ferric pyrophosphate + 15 g GOS

  • Experimental
    ferrous fumarate + 7 g GOS + Vitamin C

    labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS + Vitamin C

    Dietary Supplement: ferrous fumarate + 7 g GOS + 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

06

What researchers measure

Primary outcomes

  1. fractional iron absorption

    Fractional 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.

    Time frame: 2 months

07

Study locations

1 site
  • Human Nutrition Laboratory, ETH Zurich
    Zurich, 8092, Switzerland
08

References and documents

Publications

  • Jeroense FMD, Zeder C, Zimmermann MB, Herter-Aeberli I. Acute Consumption of Prebiotic Galacto-Oligosaccharides Increases Iron Absorption from Ferrous Fumarate, but not from Ferrous Sulfate and Ferric Pyrophosphate: Stable Iron Isotope Studies in Iron-Depleted Young Women. J Nutr. 2020 Sep 1;150(9):2391-2397. doi: 10.1093/jn/nxaa199. PubMed 32692367 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03762148
Lead sponsor
Isabelle Herter-Aeberli
Collaborators
Burgerstein Vitamine
Responsible party
Isabelle Herter-Aeberli (PhD, Swiss Federal Institute of Technology) — Sponsor-investigator
First posted
Dec 3, 2018
Start date
Apr 1, 2019
Primary completion
Jun 11, 2019
Completion
Jun 11, 2019
Last update
Jul 25, 2019

Study contacts

Isabelle Herter-Aeberli, Dr.
principal investigator · University of Zurich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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