Vitamin B12 Biomarker Responses to Supplementation

Plain-language summary

This study evaluated biomarker responses to supplementation with folic acid and different doses of vitamin B12. Healthy volunteers aged 18 or older who did not meet the exclusion criteria could take part. This study without an assigned phase has been carried out and is completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Ulster

Intervention

Folic Acid, 2 µg Vitamin B12, 10 µg Vitamin B12, 50 µg Vitamin B12

Start date

10/1/2004

Estimated completion

12/12/2006

Countries

United Kingdom

Related genes

Locations

• Coleraine, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Healthy volunteers aged 18 years and above who do not comply with the exclusion criteria

Exclusion Criteria:

* History of gastrointestinal, hepatic, renal, vascular or haematological diseases, or diabetes;
* Use of medication known to interfere with B12 metabolism (e.g. methotrexate, proton pump inhibitor drugs);
* Use of B vitamin supplements;
* Pregnancy;
* Plasma creatinine concentration \> 130 µmol/L;
* Hypochlorhydria (diagnosed serologically by pepsinogen I to Pepsinogen II ratio \< 3);
* Score of less than 25 on Folstein's Mini-Mental State Examination (a cognitive function screening test; for people aged 60 years and over);
* 677C→T polymorphism in the MTHFR gene