Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001033336
Ethics application status
Approved
Date submitted
7/07/2017
Date registered
17/07/2017
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot trial examining the absorption of oral forms of folic acid supplementation in a healthy population
Scientific title
A pilot trial examining the absorption of oral forms of folic acid supplementation in a healthy population
Secondary ID [1] 292299 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Increasing serum folate levels 303828 0
Condition category
Condition code
Diet and Nutrition 303202 303202 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will be randomly allocated into one of three groups. They will take 500 mcg of either folic acid, folinic acid or 5-MTHF oral supplements once per day for 4 weeks. A supplement diary will be provided for participants to indicate when they have taken their supplements. Participant are also asked to bring there supplement pots back at the conclusion of the trial so that any remaining supplements can be counted and recorded to assess compliance.

Intervention code [1] 298473 0
Treatment: Other
Comparator / control treatment
The control group will not take any supplements and will continue to follow there normal diet. A ll participants will be provided with a food diary to record all meals so folate intake from food can be monitored.
Control group
Active

Outcomes
Primary outcome [1] 302578 0
Changes in serum folate levels comparing folate, folinic acid and MTHF oral administration compared to control.
Timepoint [1] 302578 0
At baseline, 2 weeks and four weeks. Primary endpoint at 4 weeks.
Secondary outcome [1] 336415 0
Changes in serum folate just between the folate derivatives: folic acid, folate and MTHF.
Timepoint [1] 336415 0
Baseline, 2 weeks and 4 weeks
Secondary outcome [2] 336703 0
Comparing serum folate levels between folate derivative oral administration.
Timepoint [2] 336703 0
Baseline, 2 weeks and 4 weeks.

Eligibility
Key inclusion criteria
Healthy individuals
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy or lactation.
Have a diagnosed malabsorption conditions such as Crohns or coeliac disease.
Has a major diagnosed mental condition such as schizophrenia.
If they are taking medications which interfere with folate absorption such as anticonvulsants, metformin, antacids, non-steroidal anti-inflammatory drugs (NSAIDs) and the oral contraceptive pill (OCP).

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)
https://www.randomizer.org/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis for this pilot trial involve:
1. Comparison of participants: test of proportions: Chi-square test
2. Comparing variables over 3 time points will involve repeated measure ANOVA, mixed model and paired T-tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/08/2017
Actual
7/08/2017
Date of last participant enrolment
Anticipated
1/09/2017
Actual
11/10/2017
Date of last data collection
Anticipated
30/09/2017
Actual
16/11/2017
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 16570 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 296696 0
Commercial sector/Industry
Name [1] 296696 0
Endeavour College of Natural Health
Country [1] 296696 0
Australia
Funding source category [2] 296845 0
Commercial sector/Industry
Name [2] 296845 0
BioMedica
Country [2] 296845 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Endeavour College of natural health
Address
Level 1, 368 Elizabeth St
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 295657 0
Commercial sector/Industry
Name [1] 295657 0
BioMedica
Address [1] 295657 0
Unit 14, 34-36 Ralph Street, Alexandria NSW, 2015
Country [1] 295657 0
Australia
Secondary sponsor category [2] 295925 0
Commercial sector/Industry
Name [2] 295925 0
Bioceuticals
Address [2] 295925 0
Unit 1 / Level 1, 85 O'Riordan St
Alexandria NSW 2015
Country [2] 295925 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297926 0
Endeavour College of Natural Health
Ethics committee address [1] 297926 0
269 Wickham Tce
Fortitude Valley Qld 4006
Ethics committee country [1] 297926 0
Australia
Date submitted for ethics approval [1] 297926 0
26/06/2017
Approval date [1] 297926 0
06/07/2017
Ethics approval number [1] 297926 0
HREC Approval Number: 20170761

Summary
Brief summary
Purpose of this Study:
To investigate the safety and efficacy of oral forms of folate supplements in healthy individuals. The aim of this study is to see if there is a difference between the different forms for absorption and utilisation by the body and to see if there is a difference in efficacy between the different forms. This is an important study as it will help clinicians and the general public make informed choices.

Procedure:
One capsule per day of 500mcg of either L-5-methyltetrahydrofolate (5-MTHF), folinic acid or folic acid or a control group with no supplementation for four weeks.

Visit 1- Baseline and Beginning of Treatment (Week 1)
Blood pathology tests for MTHFR, serum folate and vitamin B12. A case report and food diary.


Visit 2 - Mid Treatment (Week 2)
Serum folate blood testing and food diary

End of Treatment – Visit 3 (Week 4)
Serum folate blood testing and food diary

Discomforts and Risks
Folate is generally considered safe and is essentially non-toxic. More than 15mg can cause abdominal distention, hyperactivity, nausea, sleep disturbances and vivid dreams. There are some concerns that folate supplements can mask a B12 deficiency so this will be measured at baseline.

Benefits
The information you provide during the study will help to guide further research which will inform clinicians and the general public about the effectiveness of different oral forms of folate supplements.

Participant Protection and Voluntary Participation
Participation in the trial is voluntary. Information that is supplied for the study will be maintained in strict confidence and will be de-identified to protect the participant’s privacy. You are entitled to withdraw from the study at any time.

Findings
Findings from the study will be published in the form of reports, journal articles and conferences or local presentations. Published results will not include your name or any information that could identify you.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75478 0
Miss Jessica Bayes
Address 75478 0
Endeavour college of natural health, 368 Elizabeth St, Melbourne VIC 3000
Country 75478 0
Australia
Phone 75478 0
+61 401962947
Fax 75478 0
Email 75478 0
[email protected]
Contact person for public queries
Name 75479 0
Dr Janet Schloss
Address 75479 0
Endeavour college of natural health, Level 2, 269 Wickham Tce
Fortitude Valley Qld 4006
Country 75479 0
Australia
Phone 75479 0
+61 7 32539579
Fax 75479 0
Email 75479 0
[email protected]
Contact person for scientific queries
Name 75480 0
Dr Nitish Agrawal
Address 75480 0
Endeavour college of natural health, C/O 269 Wickham Tce
Fortitude Valley Qld 4006
Country 75480 0
Australia
Phone 75480 0
+61 410836873
Fax 75480 0
Email 75480 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA pilot trial examining the absorption of oral forms of folate supplementation in a healthy population: A randomised control trial.2019https://dx.doi.org/10.1016/j.aimed.2018.09.005
N.B. These documents automatically identified may not have been verified by the study sponsor.