Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004994

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of this research project is to investigate whether a sufficient supply of vitamin B12 and vitamin D can be guaranteed with a whole food vegan diet (without vitamin supplements). The diet will be enriched with nori algae (containing high amounts of vitamin B12) and sun-dried mushrooms (containing high amounts of vitamin D)
Background:
In comparison to the general population, vegetarians suffer less from coronary heart diseases and cancers. Their mortality rate is also lower. Nevertheless there is a concern that people who follow a vegetarian diet suffer from vitamin B12 and vitamin D deficiencies. According to present scientific knowledge, vegetarian foods do not provide a sufficient amount of vitamin B12 and vitamin D. On the other hand, recent research results demonstrate that nori algae, wild mushrooms, and other organically grown foods contain a certain amount of vitamin B12 which the human body can absorb. Wild edible mushrooms, especially when they had been dried in the sun, were also found to contain a high to very high content of vitamin D2.
The aim of this study is to determine the relationship between a diet enriched with mushrooms, algae, and organically grown foods to blood levels of vitamin B12 and D. For this purpose blood samples were taken on five occasions within an eight month period. The first and last investigations also included a stool survey and a questionnaire.
Participants:
- Members of the Sabbath Rest Advent Church, who live on a vegetarian or vegan diet (estimated: 50 participants)
- Other vegetarians or vegans (patients of the health clinic in Dickendorf and others) (estimated: 10 participants)
- Meat eaters (patients of the health clinic in Dickendorf and others) (estimated: 10 persons)
The purpose of this study is to contribute to an optimum vegan diet containing all nutrients in sufficient quantities, and specifically to test whether the ingestion of nori algae and sundried mushrooms could prevent vitamin B12 and vitamin D deficiencies.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Background and leading question: The health benefits of a vegan and a vegetarian diet could effectively counteract many of the present civilization diseases. This study investigates whether the human body can be guaranteed a sufficient supply of vitamin B12 and vitamin D by a whole food vegan diet (including nori algae and sundried mushrooms, excluding vitamin B12 supplements).
Study design: Within a time period of eight months, blood samples were tested on five occasions. The first and last investigations also included a stool survey and a questionnaire. Four different groups were included:
Group 1: vegan without supplements. Included in this diet are nori algae (min. 12 g/week) and sun-dried wild edible mushrooms (min. 15g/week).
Group 2: vegan with supplements
Group 3: vegetarian
Group 4: meat eaters
Tested parameters: Total B12, bioactive B12, holotranscobalamin (HTRC), homocysteine (HCY), methylmalonic acid (MMA), vitamin B6, folic acid, blood count, ferrtin, tsh, zinc, creatinin. Bioactive B12 is a new parameter which is used for the first time in a scientific study.
Participants:
- Members of the Sabbath Rest Advent Church, who live on a vegetarian or vegan diet (estimated: 50 participants)
- Other vegetarians or vegans (patients of the health clinic in Dickendorf and others) (estimated: 10 participants)
- Meat eaters (patients of the health clinic in Dickendorf and others) (estimated: 10 persons)
Financial support: This research is carried out by the health clinic in Dickendorf (Germany), supported by Immundiagnostic AG in Bensheim (Germany), the MVZ in Koblenz (Germany), and Ganzimmun Diagnostics (Germany).
Patient information: the participants were informed about the research study in person and in writing and their written agreement was ascertained. The ethic commission of the Landesärztekammer Rheinland Pfalz gave their approval.
Statistics: The following statistics were done using Microsoft Excel and SPSS: a comparison of means of the four groups; follow-up monitoring of the blood results; correlations of the different parameters of the B12 analysis.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004994
  •   2013/05/28
  •   [---]*
  •   yes
  •   Approved
  •   837.109.11(7651), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   D51.3 -  Other dietary vitamin B deficiency anaemia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Group 1: vegan without supplements. Included in this diet are nori algae (min. 12 g/week) and sun-dried wild edible mushrooms (min. 15g/week).
    5 test periods: October 2011, December 2011, February 2012, April 2012, June 2012
    Tested parameters: Total B12, bioactive B12, holotranscobalamin (HTRC), homocysteine (HCY), methylmalonic acid (MMA), vitamin B6, folic acid, blood count, ferrtin, tsh, zinc, creatinin.
    The first and last investigations also included a stool survey and a questionnaire.
    Participants: Aim 25 persons
    - Members of the Sabbath Rest Advent Church, who live on a vegan diet and do not take supplements
    - Other vegans who do not take supplements (patients of the health clinic in Dickendorf and others)
  •   Group 2: vegan with supplements
    5 test periods: October 2011, December 2011, February 2012, April 2012, June 2012
    Tested parameters: Total B12, bioactive B12, holotranscobalamin (HTRC), homocysteine (HCY), methylmalonic acid (MMA), vitamin B6, folic acid, blood count, ferrtin, tsh, zinc, creatinin.
    The first and last investigations also included a stool survey and a questionnaire.
    Participants: Aim 15 persons
    - Members of the Sabbath Rest Advent Church, who live on a vegan diet and take supplements
    - Other vegans who take supplements (patients of the health clinic in Dickendorf and others)
  •   Group 3: vegetarian
    5 test periods: October 2011, December 2011, February 2012, April 2012, June 2012
    Tested parameters: Total B12, bioactive B12, holotranscobalamin (HTRC), homocysteine (HCY), methylmalonic acid (MMA), vitamin B6, folic acid, blood count, ferrtin, tsh, zinc, creatinin.
    The first and last investigations also included a stool survey and a questionnaire.
    Participants: Aim 20 persons
    - Members of the Sabbath Rest Advent Church, who live on a vegetarian diet
    - Other vegetarians (patients of the health clinic in Dickendorf and others)
  •   Group 4: meat eaters
    5 test periods: October 2011, December 2011, February 2012, April 2012, June 2012
    Tested parameters: Total B12, bioactive B12, holotranscobalamin (HTRC), homocysteine (HCY), methylmalonic acid (MMA), vitamin B6, folic acid, blood count, ferrtin, tsh, zinc, creatinin.
    The first and last investigations also included a stool survey and a questionnaire.
    Participants: Aim 10 persons
    - Meat eaters (patients of the health clinic in Dickendorf and others)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Parallel
  •   [---]*
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary outcome:
Serum level of: Total B12, bioactive B12, holotranscobalamin, homocysteine, methylmalonic acid, mean cellular volume, vitamin D2 and D3

Time of investigation:
5 investigations in 8 months (every second month) from october 2011 to june 2012

Method:
Laboratory tests:
Total B12: CLIA
Holotranscobalamin: CMIA
Bioactive B12: direct MTP essay
Homocysteine: HPLC
Methylmalonic acid: LC-MS/MS
Vitamin D2 and D3: HPLC and LC-MS/MS

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary outcome:
Bioactive B12: correlation coeffizient in connection with: Total-B12, Holotranscobalamin, Methylmalonic acid
Statitstics will be done after the end of patent investigations (6/2012);
Statistics will be done with Excel and SPSS

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/08/11
  •   70
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   16   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Gesundheitspraxis Dickendorf
    • Mr.  Dr  Joachim  Schwarz 
    • Waldstr. 44
    • 57520  Dickendorf
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Immundiagnostic AG
    • Mr.  Dr  Franz-Paul  Armbruster 
    • Stubenwald-Allee 8a
    • 64625  Bensheim
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Ganzimmun Diagnostics AG
    • Mr.  Dr  Ralf  Kirkamm 
    • Hans-Böcklerstr. 109
    • 55128  Mainz
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Medizinisches Versorgunszentrum für Laboratoriumsmedizin, Koblenz
    • Mr.  Dr  Martin  Kirsch 
    • Viktoriastr. 39
    • 56068  Koblenz
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Gesundheitspraxis Dickendorf
    • Mr.  Dr  Joachim  Schwarz 
    • Waldstr.44
    • 57520  Dickendorf
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Gesundheitspraxis Dickendorf
    • Mr.  Dr  Joachim  Schwarz 
    • Waldstr.44
    • 57520  Dickendorf
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Gesundheitspraxis Dickendorf
    • Mr.  Dr  Joachim  Schwarz 
    • Waldstr.44
    • 57520  Dickendorf
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address materialSupport
    • Immundiagnstik AG
    • Mr.  Dr  Franz-Paul  Armbruster 
    • Stubenwald-Allee 8a
    • 64625  Bensheim
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2012/06/11
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.