NCT03996421

Brief Summary

The aim is to investigate the mechanism by which galacto-oligosaccharide acutely increases iron absorption by using stable isotope appearance curves. This will allow the evaluation of changes in serum iron isotopes over the first few hours after administration of the iron supplement and provides information where and in what amount iron absorption takes place in the GI-tract.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 23, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2019

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1 month

First QC Date

June 6, 2019

Last Update Submit

December 6, 2019

Conditions

Low Iron Stores

Keywords

Low iron storesPrebioticsGalacto-oligosaccharides

Outcome Measures

Primary Outcomes (2)

  • serum iron isotope concentration

    serum iron isotope concentration from ferrous fumarate with or without the addition of GOS at all the different time points. Serum iron isotope concentration absorbed from the iron supplements will be calculated based on the shift of the iron isotope ratios in the collected blood samples at least 14 days after the last administration of the isotopically labelled supplements.The iron isotope ratios in the collected blood samples will be measured using an ICP-mass spectrometry instrument (NEPTUNE, Thermo Finnigan).

    29 days

  • total fractional iron absorption

    total iron fractional absorption from ferrous fumarate with or without the addition of GOS at all the different time points. Fractional absorption of iron (%) from the iron supplements will be calculated based on the shift of the iron isotope ratios in the collected blood samples at least 14 days after the last administration of the isotopically labelled supplements.The iron isotope ratios in the collected blood samples will be measured using an ICP-mass spectrometry instrument (NEPTUNE, Thermo Finnigan).

    29 days

Secondary Outcomes (5)

  • Haemoglobin (Hb)

    29 days

  • serum ferritin (SF)

    29 days

  • serum transferrin receptor (sTfR)

    29 days

  • alpha-1-acid glycoprotein (AGP)

    29 days

  • C - reactive protein (CRP)

    29 days

Study Arms (2)

ferrous fumarate

EXPERIMENTAL

labelled iron as ferrous fumarate

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

ferrous fumarate + 15 g GOS

EXPERIMENTAL

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

Dietary Supplement: ferrous fumarate + 15 g GOS

Interventions

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

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

ferrous fumarate
ferrous fumarate + 15 g GOSDIETARY_SUPPLEMENT

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

ferrous fumarate + 15 g GOS

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants are being studied
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female, 18 to 45 years old
  • SF levels 15-30 µg/L
  • Normal body Mass Index (18.5-24.9 kg/m2)
  • Body weight \<70 kg
  • Signed informed consent

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Human Nutrition, ETH Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

  • Jeroense FMD, Michel L, Zeder C, Herter-Aeberli I, Zimmermann MB. Consumption of Galacto-Oligosaccharides Increases Iron Absorption from Ferrous Fumarate: A Stable Iron Isotope Study in Iron-Depleted Young Women. J Nutr. 2019 May 1;149(5):738-746. doi: 10.1093/jn/nxy327.

    PMID: 31004135BACKGROUND

  • Husmann FMD, Stierli L, Bram DS, Zeder C, Kramer SD, Zimmermann MB, Herter-Aeberli I. Kinetics of iron absorption from ferrous fumarate with and without galacto-oligosaccharides determined from stable isotope appearance curves in women. Am J Clin Nutr. 2022 Mar 4;115(3):949-957. doi: 10.1093/ajcn/nqab361.

    PMID: 34726703DERIVED

MeSH Terms

Interventions

ferrous fumarate

Study Officials

  • Isabelle Herter-Aeberli, Dr.

    Laboratory of Human Nutrition ETH Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigatior

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 24, 2019

Study Start

October 23, 2019

Primary Completion

November 27, 2019

Study Completion

November 27, 2019

Last Updated

December 10, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)