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Does a whole-food, vegan diet provide the body with a sufficient supply of vitamin B12 and vitamin D?A follow-up study

Not Applicable
Conditions
D51.3
Other dietary vitamin B<Term class=subscript>12</Term> deficiency anaemia
Registration Number
DRKS00004994
Lead Sponsor
Gesundheitspraxis Dickendorf
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
80
Inclusion Criteria

Minimum age: 16 years, both sexes, all nationalities
-Participants must be of legal age or must present a written agreement of their custodian
-Participants must be in good health
-Participants must not suffer from a lack of vitamin B12 or vitamin D as a result of a disease
-Participants must have followed their present diet (vegetarian or vegan) for at least two years

Exclusion Criteria

-Persons who suffer from a lack of vitamin B12 or vitamin D as a result of a disease
-Persons whose ability to reason could be doubted

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary outcome:<br>Serum level of: Total B12, bioactive B12, holotranscobalamin, homocysteine, methylmalonic acid, mean cellular volume, vitamin D2 and D3<br><br>Time of investigation:<br>5 investigations in 8 months (every second month) from october 2011 to june 2012<br><br>Method:<br>Laboratory tests:<br>Total B12: CLIA<br>Holotranscobalamin: CMIA<br>Bioactive B12: direct MTP essay<br>Homocysteine: HPLC<br>Methylmalonic acid: LC-MS/MS<br>Vitamin D2 and D3: HPLC and LC-MS/MS
Secondary Outcome Measures
NameTimeMethod
Secondary outcome:<br>Bioactive B12: correlation coeffizient in connection with: Total-B12, Holotranscobalamin, Methylmalonic acid<br>Statitstics will be done after the end of patent investigations (6/2012);<br>Statistics will be done with Excel and SPSS
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