Status:
COMPLETED
Vitamin B12 Biomarker Responses to Supplementation
Lead Sponsor:
University of Ulster
Collaborating Sponsors:
University of Dublin, Trinity College
University of Bergen
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to investigate the response of recognized biomarkers of vitamin B12 status to intervention with supplemental vitamin B12 at doses within and beyond the range of typical dietary...
Detailed Description
Detailed Description: The aim of this study is to investigate the response of recognized vitamin B12 biomarkers (serum total vitamin B12; serum holotranscobalamin; plasma methylmalonic acid; plasma h...
Eligibility Criteria
Inclusion
- Healthy volunteers aged 18 years and above who do not comply with the exclusion criteria
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04731948
Start Date
October 1 2004
End Date
December 12 2006
Last Update
February 1 2021
Active Locations (1)
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1
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, United Kingdom, BT52 1SA