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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05033483
Registration number
NCT05033483
Ethics application status
Date submitted
13/08/2021
Date registered
2/09/2021
Date last updated
12/04/2023
Titles & IDs
Public title
Do Iron Supplements Impact the Gut Microbiome of Women of Reproductive Age?
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Scientific title
Do Iron Supplements Impact the Gut Microbiome of Women of Reproductive Age?
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Secondary ID [1]
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Iron Mic
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Iron-deficiency
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Microbial Colonization
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Anemia
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Condition category
Condition code
Infection
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0
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Studies of infection and infectious agents
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Infection
0
0
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0
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Other infectious diseases
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Infection
0
0
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0
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Sexually transmitted infections
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Metabolic and Endocrine
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0
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0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Ferrous Fumarate
Other interventions - Placebo
Experimental: Iron Supplement - 65.7 mg of iron as ferrous fumarate
Active Comparator: Placebo - 0 mg of iron
Other interventions: Ferrous Fumarate
Gelatin capsule containing 200 mg ferrous fumarate and microcrystalline cellulose
Other interventions: Placebo
Gelatin capsule containing microcrystalline cellulose
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Weighted UniFrac dissimilarity score
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Assessment method [1]
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Measure of microbiota beta-diversity
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Timepoint [1]
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21 days
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Secondary outcome [1]
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Bray-Curtis dissimilarity score
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Assessment method [1]
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Measure of microbiota beta-diversity
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Timepoint [1]
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21 days
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Secondary outcome [2]
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Shannon Wiener Diversity
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Assessment method [2]
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Microbiota alpha-diversity score with adjustment for baseline levels
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Timepoint [2]
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21 days
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Secondary outcome [3]
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Faith's phylogenetic diversity
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Assessment method [3]
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Microbiota alpha-diversity score with adjustment for baseline levels
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Timepoint [3]
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21 days
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Secondary outcome [4]
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Taxonomic richness
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Assessment method [4]
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Microbiota alpha-diversity score with adjustment for baseline levels
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Timepoint [4]
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21 days
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Secondary outcome [5]
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Relative abundance of core bacterial taxa
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Assessment method [5]
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Relative abundance of taxa present in >40% of baseline samples, with adjustment for baseline levels
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Timepoint [5]
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21 days
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Eligibility
Key inclusion criteria
- Able to give informed consent
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2022
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Sample size
Target
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Accrual to date
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Final
82
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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SAHMRI - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
South Australian Health and Medical Research Institute
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Address
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Country
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Other collaborator category [1]
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0
Other
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Name [1]
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Flinders University
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Address [1]
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0
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05033483
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Steven Taylor, PhD
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Address
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South Australian Health and Medical Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05033483
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