A pilot trial examining the absorption of oral forms of folic acid supplementation in a healthy population

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001033336

Acronym

None

Enrollment

Registered

2017-07-17

Start date

2017-08-07

Completion date

2017-10-11

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy individuals

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).

Outcome results