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Completed

NCT Number: NCT01661309

Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial

Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary animal produce, which can elevate homocysteine. There is strong evidence indicating that elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.

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Key information

Conditions

Vitamin B12 Deficiency Amino Acid Metabolism, Inborn Errors Avitaminosis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Genetic Diseases, Inborn Hyperhomocysteinemia Malabsorption Syndromes Malnutrition Metabolic Diseases Metabolism, Inborn Errors Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of West London

London, Middlesex, TW8 9GA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having a plasma tHcy >10 micromol/L
  • Not suffering from conditions as described in exclusion criteria.
  • Vegetarian for at least one year.
  • Not participating in a weight reducing diet.
  • Not consuming regularly vitamin B12 supplements.
  • Give written consent to participate in clinical trial and be fluent in English language.

Exclusion criteria

  • Having a plasma tHcy less or equal to 10 micromol/L.
  • Suffering from pernicious anemia or other vitamin B12 deficiency disease.
  • Undergone bowel surgery or suffer from gastrointestinal disease.
  • Pregnant, lactating or trying to conceive.
  • Smoker.
  • Alcohol intake regularly greater than official recommended daily units (i.e. 2 units female, 3 units male).
  • Consume large amounts of caffeine (regular consumption of >4 cups of strong tea or coffee per day).
  • Use of medications known to influence nutritional status.
  • Have genetic metabolic disease.
  • Suffer from renal failure, diabetes, thyroid disease, cardiovascular disease, dementia or cancer.
  • Have a known blood-borne infection (e.g. Hepatitis or HIV).

Treatment and study plan

Inactive lozenge

Dietary Supplement

Manufactured to mimic 1mg methylcobalamin lozenge

Methylcobalamin

Dietary Supplement

Aimed at reducing plasma tHcy.

Other names: Vitamin B12

Primary outcomes

  1. Reduction of plasma total homocysteine of vegetarians

    Time frame: 16 weeks per participant

Secondary outcomes

  1. Improvement in systolic and diastolic blood pressure

    Time frame: 16 weeks per participant

Other outcomes

  1. Improvement in body mass index

    Time frame: 16 weeks per participant

Sponsors and collaborators

Lead sponsor

University of West London

Other

Registry information

Official study title

To Critically Investigate and Evaluate Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians, Who May Have a Resultant Susceptibility to Hyperhomocysteinemia Related Diseases.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 9, 2012
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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