ANZCTR - Registration

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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]

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

Condition category

Condition code

Diet and Nutrition

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]

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]

Changes in serum folate levels comparing folate, folinic acid and MTHF oral administration compared to control.

Timepoint [1]

At baseline, 2 weeks and four weeks. Primary endpoint at 4 weeks.

Secondary outcome [1]

Changes in serum folate just between the folate derivatives: folic acid, folate and MTHF.

Timepoint [1]

Baseline, 2 weeks and 4 weeks

Secondary outcome [2]

Comparing serum folate levels between folate derivative oral administration.

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3000 - Melbourne

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Endeavour College of Natural Health

Address [1]

Level 1, 368 Elizabeth St
Melbourne VIC 3000

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

BioMedica

Address [2]

Unit 14, 34-36 Ralph Street, Alexandria NSW, 2015

Country [2]

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]

Commercial sector/Industry

Name [1]

BioMedica

Address [1]

Unit 14, 34-36 Ralph Street, Alexandria NSW, 2015

Country [1]

Australia

Secondary sponsor category [2]

Commercial sector/Industry

Name [2]

Bioceuticals

Address [2]

Unit 1 / Level 1, 85 O'Riordan St
Alexandria NSW 2015

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Endeavour College of Natural Health

Ethics committee address [1]

269 Wickham Tce
Fortitude Valley  Qld 4006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/06/2017

Approval date [1]

06/07/2017

Ethics approval number [1]

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

Miss Jessica Bayes

Address

Endeavour college of natural health, 368 Elizabeth St, Melbourne VIC 3000

Country

Australia

Phone

+61 401962947

Fax

jessica.bayes@yahoo.com

Contact person for public queries

Name

Janet Schloss

Address

Endeavour college of natural health, Level 2, 269 Wickham Tce
Fortitude Valley Qld 4006

Country

Australia

Phone

+61 7 32539579

Fax

janet.schloss@endeavour.edu.au

Contact person for scientific queries

Name

Nitish Agrawal

Address

Endeavour college of natural health, C/O 269 Wickham Tce
Fortitude Valley Qld 4006

Country

Australia

Phone

+61 410836873

Fax

nitish.agrawal@endeavour.edu.au

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

Source	Title	Year of Publication	DOI
Embase	A pilot trial examining the absorption of oral forms of folate supplementation in a healthy population: A randomised control trial.	2019	https://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.

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Documents added manually

Documents added automatically