NCT05033483

Brief Summary

In this randomised controlled trial the investigators will determine whether taking iron supplements compared to placebo for 21 days alters the bacteria (microbiome) in the large intestine of non-pregnant female participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

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

August 13, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 12, 2023

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

August 13, 2021

Last Update Submit

April 11, 2023

Conditions

Iron-deficiencyMicrobial ColonizationAnemia

Keywords

iron supplementsmicrobiomewomen

Outcome Measures

Primary Outcomes (1)

  • Weighted UniFrac dissimilarity score

    Measure of microbiota beta-diversity

    21 days

Secondary Outcomes (5)

  • Bray-Curtis dissimilarity score

    21 days

  • Shannon Wiener Diversity

    21 days

  • Faith's phylogenetic diversity

    21 days

  • Taxonomic richness

    21 days

  • Relative abundance of core bacterial taxa

    21 days

Other Outcomes (6)

  • Weighted UniFrac dissimilarity score

    42 days (washout)

  • Shannon-Wiener diversity

    42 days (washout)

  • Bray-Curtis dissimilarity score

    42 days (washout)

  • +3 more other outcomes

Study Arms (2)

Iron Supplement

EXPERIMENTAL

65.7 mg of iron as ferrous fumarate

Dietary Supplement: Ferrous Fumarate

Placebo

ACTIVE COMPARATOR

0 mg of iron

Dietary Supplement: Placebo

Interventions

Ferrous FumarateDIETARY_SUPPLEMENT

Gelatin capsule containing 200 mg ferrous fumarate and microcrystalline cellulose

Also known as: Iron Fumarate, ferro-tab
Iron Supplement
PlaceboDIETARY_SUPPLEMENT

Gelatin capsule containing microcrystalline cellulose

Also known as: Control
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Able to give informed consent

You may not qualify if:

  • Pregnant or breastfeeding.
  • Planning on becoming pregnant
  • Diagnosed with iron deficiency and/or anaemia in the previous three months
  • Taken antibiotics in the past three months
  • Taken iron containing supplements in the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAHMRI

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

  • Elms L, Hand B, Skubisz M, Best KP, Grzeskowiak LE, Rogers GB, Green TJ, Taylor SL. The Effect of Iron Supplements on the Gut Microbiome of Females of Reproductive Age: A Randomized Controlled Trial. J Nutr. 2024 May;154(5):1582-1587. doi: 10.1016/j.tjnut.2024.03.014. Epub 2024 Mar 21.

    PMID: 38521191DERIVED

MeSH Terms

Conditions

Anemia, Iron-DeficiencyCommunicable DiseasesAnemia

Interventions

ferrous fumarate

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Taylor, PhD

    South Australian Health and Medical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Supplements were packaged by LifeCare Compounding Pharmacy and labelled by staff not involved in the trial, with 2 colours per treatment group. The randomisation schedule was prepared by an independent statistician. The schedule allocates women to one of the four colours in the ratio 1:1:1:1 using randomly permuted blocks.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A randomized, controlled, researcher and participant blinded trial with two parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2021

First Posted

September 2, 2021

Study Start

August 31, 2021

Primary Completion

November 6, 2021

Study Completion

January 1, 2022

Last Updated

April 12, 2023

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

Outlined below

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Following final data analysis and primary publication
Access Criteria
Access to study data may be granted, upon review and approval of the Institutional Review Board, investigators, in accordance with South Australian Health and Medical Research Institute Women and Kids 'Guidelines and Agreement for the use of materials in an ancillary study associated with original clinical trials or cohort studies.

Locations

AU(1)