Evaluation of vitamin B12 supplementation on nutritional status in vegan and vegetarian subjects

Not Applicable

Completed

• Conditions: Healthy volunteers with B12 marginal deficiency; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN75099618
• Lead Sponsor: Phoenix S.R.L. - LongLife Nutritional Supplements

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29499976 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35961278/ Association of cobalamin and vascular endothelial-cadherin in trial participants (added 15/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-04-10
• Study Start: 2017-04-28
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Healthy men/women (20-60 years of age)
2. Moderate smoking (about 5-6 cigarette/day)
3. Moderate physical activity (25-30 min per day of brisk walk or jog)
4. Moderate alcohol consumption (up to 14 drinks per week)
5. Plasma levels of vitamin B12 lower than 220 pmol / L
6. Follow a vegan diet
7. No regular intake of drugs (for any type of disease)
8. Non allergic subjects

Exclusion Criteria

1. History of cardiovascular, coronary, diabetes, hepatic, renal, or gastrointestinal diseases.
2. Use of any drugs, medications at least one month before the beginning of the experiment.
3. Use of vitamin B12 supplements at least one year before the beginning of the experiment.
4. Omnivore subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified