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

• Register: ISRCTN
• Last refreshed on: 29 August 2022
• Main ID: ISRCTN75099618
• Date of registration: 28/04/2017
• Prospective Registration: No
• Primary sponsor: Phoenix S.R.L. - LongLife Nutritional Supplements
• Public title: Evaluation of vitamin B12 supplementation on nutritional status in vegan and vegetarian subjects
• Scientific title: Evaluation of nutritional status of vitamin B12 in vegans and vegetarians with marginal deficiency after 12 weeks of supplementation with two dosages of a sublingual formulation
• Date of first enrolment: 05/05/2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN75099618
• Study type: Interventional
• Study design: 12 week two armed dietary interventional randomised parallel trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Italy

Contacts

• Name: Salvatore Ciappellano

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy volunteers with B12 marginal deficiency
Nutritional, Metabolic, Endocrine
Healthy volunteers with B12 marginal deficiency

Intervention(s)

Participants are enrolled in the study after they complete a specific questionnaire and medical examination to determine eligibility. Participants are then randomly allocated to one of two groups based on when they joined the study.

Control group (Hd- high dose): Participants are given a high vitamin B12 concentration (2000mcg/week) dietary supplement that they take weekly for three months. Supplements are given tablets that dissolve under the tongue. Participants in this group take tablets everyday but only once a week take a pill that is enriched with B12, the other six days the tablets are placebo.

Test group (Ld- low dose): Participants are given a low vitamin B12 concentration (350mcg/week) dietary supplement that they take daily for three months. Supplements are given as tablets that dissolve under the tongue and are taken daily.

Fasting blood samples (about 30 mL) are obtained from all participants, at baseline and after 15, 30, 60 and 90 days to assess Vitamin B12, holotranscobalamine, metilmalonic acid, homocysteine, folic acid, vitamin B6 and complete blood count. This is also done to monitor the modification of the nutritional status during the entire intervention.

Primary Outcome(s)

Nutritional status (vitamin B12, holotranscobalamin, methylmalonic and homocysteine concentrations) are measured using blood samples at baseline, day 15, day 30, day 60 and day 90

Secondary Outcome(s)

1. Complete blood count is measured using blood samples at baseline, day 15, day 30, day 60 and day 90
2. Serum levels of folic acid is measured using blood samples at baseline, day 15, day 30, day 60 and day 90
3. Vitamin B6 is measured using blood samples at baseline, day 15, day 30, day 60 and day 90

Secondary ID(s)

11/15 University of Milano - ethical comitee

Source(s) of Monetary Support

University of Milan, Phoenix S.R.L. - LongLife Nutritional Supplements

Ethics review

Status:
Approval date:
Contact:

Ethics Committee of the University of Milan, 04/03/2015, ref: 11/15

Results

• Results available: Yes
• Date Completed: 10/04/2017