Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001337763
Ethics application status
Approved
Date submitted
10/10/2022
Date registered
18/10/2022
Date last updated
28/04/2024
Date data sharing statement initially provided
18/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Potential Benefits of Ginger Supplementation in Individuals With
Iron Deficiency: a Randomised Controlled Pilot Study.
Scientific title
The Potential Benefits of Ginger Supplementation in Individuals With
Iron Deficiency: a Randomised Controlled Pilot Study
Secondary ID [1] 308151 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron Deficiency 327875 0
Condition category
Condition code
Blood 324957 324957 0 0
Anaemia
Diet and Nutrition 324958 324958 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral supplement of dried ginger powder in 525 mg capsule 3 times per day as an adjunct to oral iron therapy (Ferrous Fumarate 200mg 2 tablets daily for 24 weeks) under standard care for 24 weeks. Adherence is self-report during the study visit.
Intervention code [1] 324602 0
Treatment: Other
Comparator / control treatment
Oral iron therapy under standard care with Ferrous Fumarate 200mg 2 tablets daily for 24 weeks.
Control group
Active

Outcomes
Primary outcome [1] 332759 0
Serum Ferritin
Timepoint [1] 332759 0
0, 12, 24 weeks post-intervention commencement
Secondary outcome [1] 414636 0
Serum High Sensitive C-reactive Protein (hsCRP)
Timepoint [1] 414636 0
0, 12, 24 weeks post-intervention commencement
Secondary outcome [2] 414637 0
Erythrocyte Sedimentation Rate (ESR) performed on whole blood
Timepoint [2] 414637 0
0, 12, 24 weeks post-intervention commencement
Secondary outcome [3] 414638 0
Serum Hepcidin
Timepoint [3] 414638 0
0, 12, 24 weeks post-intervention commencement
Secondary outcome [4] 414639 0
Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [4] 414639 0
0, 12, 24 weeks post-intervention commencement
Secondary outcome [5] 414640 0
Fatigue Severity Scale (FSS)
Timepoint [5] 414640 0
0, 12, 24 weeks post-intervention commencement
Secondary outcome [6] 414641 0
Changes in gut microbiota composition (alpha and beta diversity) based on the 16S rRNA sequencing using stool samples.
Timepoint [6] 414641 0
0, 12, 24 weeks post-intervention commencement

Eligibility
Key inclusion criteria
1. Adults aged 18 and over
2. Confirmed iron deficiency (ID) diagnosis with SF level less than 30 µg/L with normal or slightly lower than normal Hb level (Hb greater than or equal to 110 g/L)
3. Adequately maintained liver and renal functions with the following laboratory
parameters less than 2x Upper Limit of Normal:
a. Alanine transaminase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT)
b. Blood urea nitrogen (BUN) and creatinine
4. Functional grade based on ECOG Performance Status is between 0 to 2
5. Received explanation of the purpose and methods of the study and provided written
consent at the point of recruitment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A mental health condition that may impede the patient’s ability to provide informed consent
2. Having diagnosed with an eating disorder or demonstrating certain behavioural, physical and psychological signs or changes that often accompany an eating disorder
3. Known or possible pregnancy, desire to become pregnant during the study period, or currently breastfeeding
4. Known to have an allergy to ginger or had experienced adverse reactions to ginger previously
5. Underwent any major surgery within 6 months at the time of screening or planning to undergo a major surgery during the study period
6. Had any blood transfusion to replace blood lost due to surgery or injury within the last 6 months or need to receive a blood transfusion during the study period
7. Having underlying pathology and sources of overt and occult blood loss (e.g., GIT, genitourinary, nose, mouth, etc.) that was diagnosed or currently under investigation
8. Donating blood within 8 weeks of starting the trial or during the study period
9. Having underlying conditions due to chronic disease (e.g. inflammatory bowel disease, celiac disease, autoimmune gastritis, rheumatoid arthritis, etc.), liver disease, B12 deficiency, or malignancy
10. Having active infections or other medical conditions that elevate SF and high sensitivity C-reactive protein (hsCRP) acutely
11. Previous treatment of ID with oral iron therapy within the last 1 month or intravenous iron therapy within the last 3 months
12. Currently on warfarin or any other blood-thinning medications (anticoagulants)
13. No concurrently taking other dietary supplement of iron, vitamin C, probiotics, vitamin B12, folic acid, and vitamin D during the trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation based on blocked randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pilot trial
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Outcome measures of SF, Hb, serum hepcidin, hsCRP, ESR and scoring of FSS and GSRS will be analysed using mixed ANOVA with repeated measures to detect any significant changes between groups over time. Pairwise comparisons with t-tests will be performed where significance is observed. The significance level is set at p<0.05.

Improvements in ID will be reported as response rates. The odds ratio of responding to treatment in the intervention group will be compared to the responding rate of the control group with the significance computed using Fisher’s Exact Probability Test.

The 16S rRNA sequences of extracted faecal DNA will be analysed with QIIME2
(Quantitative Insights into Microbial Ecology software) pipeline.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
30/03/2023
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
20
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312413 0
Charities/Societies/Foundations
Name [1] 312413 0
Australian Traditional-Medicine Society (ATMS)
Country [1] 312413 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
The Oaks Medical Practice
Address
4/73 John Street,
The Oaks
NSW 2570
Country
Australia
Secondary sponsor category [1] 313982 0
None
Name [1] 313982 0
Address [1] 313982 0
Country [1] 313982 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311760 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 311760 0
Ethics committee country [1] 311760 0
Australia
Date submitted for ethics approval [1] 311760 0
04/02/2022
Approval date [1] 311760 0
02/05/2022
Ethics approval number [1] 311760 0
2022/ETH00195

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122270 0
Dr Ron Campbell
Address 122270 0
The Oaks Medical Practice,
4/73 John Street,
The Oaks NSW 2570
Country 122270 0
Australia
Phone 122270 0
+61 2 4657 1120
Fax 122270 0
Email 122270 0
[email protected]
Contact person for public queries
Name 122271 0
Ron Campbell
Address 122271 0
The Oaks Medical Practice,
4/73 John Street,
The Oaks NSW 2570
Country 122271 0
Australia
Phone 122271 0
+61 2 4657 1120
Fax 122271 0
Email 122271 0
[email protected]
Contact person for scientific queries
Name 122272 0
Ron Campbell
Address 122272 0
The Oaks Medical Practice,
4/73 John Street,
The Oaks NSW 2570
Country 122272 0
Australia
Phone 122272 0
+61 2 4657 1120
Fax 122272 0
Email 122272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data of published results only
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
May be shared with the funding body or other institutions for research use upon request.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Subject to approvals by Principal Investigator (Dr Ron Campbell, [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.