Vitamin B12 Nutritional DeficiencyNORMB12NCT05785585
Effect of Methylcobalamin and Cyanocobalamin Consumption on Vitamin B12 Nutritional Status
A study testing Methylcobalamin and Cyanocobalamin group in people with Vitamin B12 Nutritional Deficiency, run by Fundació Eurecat at 2 sites in Spain.
Trial summary
Vitamin B12 (B12, Cobalamin) is an essential micronutrient that humans are not capable of synthesizing and therefore must be ingested through food. In nature, B12 is basically only present in foods of animal origin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin B12 Nutritional Deficiency
- What is being tested?
- Methylcobalamin and Cyanocobalamin group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesSpain
- Study dates
- 9 Sep 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 years or older who follow a vegetarian diet.
- Present serum vitamin B12 levels of 148-221 pmol/L and absence of symptoms associated with vitamin B12 deficiency.
- Sign the informed consent.
- Read, write and speak Catalan or Spanish.
Who cannot join
- Present diagnosed diseases that may interfere with vitamin B12 markers, including gastrointestinal diseases (such as inflammatory bowel disease, celiac disease, ileal resection, Crohn's disease, constipation or atrophic gastritis), pancreatic diseases, kidney diseases, liver diseases, diabetes, cardiovascular diseases, pernicious anemia and cancer.
- Medical history of abdominal surgery that may influence the absorption of vitamin B12 (such as bariatric surgery).
- Being on hemodialysis treatment.
- Present values of body mass index ≤ 18.5 kg/m^2 or ≥ 35 kg/m^2.
- Present anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women).
- Having consumed or consume vitamin B12 or folate supplements for more than 2 months before inclusion in the study.
Show all 13Show fewer
- Have taken medications that affect the absorption and therapeutic response of vitamin B12 (such as methotrexate, metformin, proton pump inhibitors, H2 receptor antagonists, histamine, nitrous oxide, colchicine, neomycin, biguanides, cholestyramine, aminosalicylic acid, chloramphenicol and other bone marrow depressants) one month before inclusion in the study.
- Be a smoker or ex-smoker in the last 6 months before inclusion in the study.
- Take 2 or more Standard Beverage Units (SBU) daily or 17 SBU weekly for women, or take 4 or more SBU daily or 28 SBU weekly for men.
- Present allergy or intolerance to the study products (microcrystalline cellulose, vitamin B12 or cobalt).
- Being pregnant or intending to become pregnant.
- Being in breastfeeding period.
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days before inclusion in the study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Fundació Eurecat
Reus, Tarragona, 43204
Antoni Caimari, PhD, 0034 977 300 431, antoni.caimari@eurecat.org
Anna Crescenti, PhD, 0034 977 300 431, anna.crescenti@eurecat.org
- Recruiting
Eurecat
Reus, 43204
Antoni Caimari, PhD, 0034 977 300 431, antoni.caimari@eurecat.org
Anna Crescenti, PhD, 0034 977 300 431, anna.crescenti@eurecat.org
About this study
Official title: Effect of Methylcobalamin and Cyanocobalamin Consumption on Vitamin B12 Nutritional Status in Vegetarians With Marginal Vitamin B12 Deficiency. Randomized, Parallel, Placebo-Controlled, Triple-Blind Clinical Trial.
Vitamin B12 (B12, Cobalamin) is an essential micronutrient that humans are not capable of synthesizing and therefore must be ingested through food. In nature, B12 is basically only present in foods of animal origin.
B12 deficiency is a clinically important condition that is associated with several metabolic disorders such as megaloblastic anemia, hyperhomocysteinemia, and cardiovascular, cerebrovascular, and neurological disorders. Therefore an optimal intake of B12 is important.
Read more
B12 deficiency occurs when B12 stores are depleted due to inadequate dietary intake or impaired absorption of B12. Because B12 is only present in foods of animal origin, following an unbalanced vegetarian diet is associated with increased risk of developing nutritional deficiencies due to the exclusion of meat and fish from their diet, including vitamin B12 deficiency.
There are a variety of forms of vitamin B12 used in vitamin B12 supplements. All these forms share the structure of Cobalamin but contain different ligands. Cyanocobalamin (CNCbl) is a synthetic, stable, and inexpensive form widely used in B12 supplements. MethylCobalamin (MeCbl) is a physiological form of cobalamin, called metabolically active form of vitamin B12. Interest in substituting CNCbl form with the physiological form MCbl has recently increased, assuming that it will be more effective.
The main objective of the study is to evaluate the effect of Methylcobalamin consumption, compared to Cyanocobalamin consumption, on the nutritional status of vitamin B12 in a vegetarian population with marginal vitamin B12 deficiency.
The secondary objectives of the study are to evaluate the effects of Methylcobalamin consumption, compared to Cyanocobalamin consumption, on markers of vitamin B12 deficiency: Holotranscobalamin, Methylmalonic acid, Homocysteine and 4cB12.
During the study there will be 8 visits: a preselection visit (V0; day -7) and 7 study visits during the consumption of the treatments, which will take place on the first day of the study (V1; day 1), after 8 days of treatment (V2; day 8), at 15 days of treatment (V3; day 15), at 29 days of treatment (V4; day 29), at 43 days of treatment (V5; day 43), at 64 days of treatment (V6; day 64), and at 85 days of treatment (V7; day 85).
- Conditions
- Vitamin B12 Nutritional Deficiency
- Being tested
- Methylcobalamin, Cyanocobalamin group, Control group
- Keywords
- Vitamin B12, Methylcobalamin, Cyanocobalamin, Vegetarians, Holotranscobalamin, Methylmalonic acid, Homocysteine, 4cB12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylcobalaminDietary supplement
Treatment with Methylcobalamin during 12 weeks
Cyanocobalamin groupDietary supplement
Treatment with Cyanocobalamin during 12 weeks
Control groupDietary supplement
Treatment with microcrystalline cellulose during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Methylcobalamin group | Experimental | One capsule daily with 500 µg of methylcobalamin for 12 weeks Receives: Dietary Supplement: Methylcobalamin |
| Cyanocobalamin group | Active comparator | One capsule daily with 500 µg of Cyanocobalamin for 12 weeks Receives: Dietary Supplement: Cyanocobalamin group |
| Control group | Placebo comparator | One capsule daily with microcrystalline cellulose for 12 weeks Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of total vitamin B12 in blood.
Serum total vitamin B12 will be measured by chemiluminescence immunoassay.
Measured: At day -7 (pre-selection visit), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Secondary outcomes (20)
Levels of Holotranscobalamin in blood.
Serum Holotranscobalamin will be measured by chemiluminescence immunoassay.
Measured: At day -7 (pre-selection visit), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Levels of Methylmalonic acid in blood.
Serum Methylmalonic acid will be measured by Liquid Chromatography coupled to tandem Mass Spectrometry.
Measured: At day -7 (pre-selection visit), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Levels of Homocysteine in blood.
Plasma Homocysteine will be measured by Liquid Chromatography coupled to tandem Mass Spectrometry.
Measured: At day -7 (pre-selection visit), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Levels of 4cB12 marker.
The 4cB12 marker will be calculated from the blood levels obtained for total vitamin B12, Holotranscobalamin, Methylmalonic acid and Homocysteine using the formula log10((B12 x Holotranscobalamin)/(Methylmalonic acid x Homocysteine)).
Measured: At day -7 (pre-selection visit), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Levels of folate in blood.
Serum folate will be measured by chemiluminescence immunoassay.
Measured: At day -7 (pre-selection visit) and day 85 (visit 7).
Levels of vitamin B6 in blood.
Plasma vitamin B6 will be measured by Ultra High Performance Liquid Chromatography coupled to tandem Mass Spectrometry.
Measured: At day -7 (pre-selection visit) and day 85 (visit 7).
Health related quality of life.
Health related quality of life will be assessed using the SF-36 questionnaire (36-item short form survey) in Spanish. The SF-36 questionnaire consists of the subscales general health (5 items), mental health (5 items), emotional role (3 items), social function (2 items), vitality (4 items), physical function (10 items), physical role (4 items) and bodily pain (2 items). The items on the scale are ordered in such a way that the higher the score, the higher the state of health. Scores on each of the SF-36 scales range from 0 to 100.
Measured: At day 1 (visit 1) and day 85 (visit 7).
Dietary habits and caloric intake.
Nutritional habits and caloric intake will be determined based on the results obtained from the 3-day dietary record.
Measured: At day 1 (visit 1) and day 85 (visit 7).
Consumption of foods with vitamin B12.
Consumption of foods with vitamin B12 by the volunteers will be determined by analyzing the questionnaire on the frequency of consumption of foods with vitamin B12.
Measured: At day 1 (visit 1), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Compliance with dietary recommendations.
The adherence to the dietary recommendations by the volunteers will be determined by analyzing the 24h dietary recall.
Measured: At day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), and day 64 (visit 6).
Physical activity.
Physical activity will be evaluated through the International Physical Activity Questionnaire (IPAQ)-short for physical activity questionnaire.
Measured: At day 1 (visit 1) and day 85 (visit 7).
Concomitant medication.
The consumption of concomitant medication by te volunteers will be controlled by the record of concomitant medication in the case report form.
Measured: At day 1 (visit 1), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Consumption of food supplements.
The consumption of food supplements by te volunteers will be controlled by the record of food supplements in the case report form.
Measured: At day 1 (visit 1), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Body weight.
Body weight measured by standardized method.
Measured: At day 1 (visit 1) and day 85 (visit 7).
Height.
Height measured by standardized method.
Measured: At day -7 (pre-selection visit).
Body Mass Index.
Weight and height will be combined to report Body Mass Index in kg/m^2.
Measured: At day 1 (visit 1) and day 85 (visit 7).
Age.
The age of the volunteers will be recorded in the case report form.
Measured: At day -7 (pre-selection visit).
Gender.
The gender of the volunteers will be recorded in the case report form.
Measured: At day -7 (pre-selection visit).
Intervention compliance.
The intervention compliance by te volunteers will be assessed by counting the number of remaining capsules and applying the formula (Number of capsules consumed/Number of capsules to consume)x100.
Measured: At day 43 (visit 5) and day 85 (visit 7).
Adverse events.
Possible adverse events derived from taking study's products will be recorded in the case report form.
Measured: At day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start9 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin B12 Nutritional DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratorio Echevarne, Health Tech Bio Actives, S.L.U.
- Responsible party
- Principal investigator, Antoni Caimari, Fundació Eurecat
- Investigators
- Antoni Caimari, PhD, Principal investigator, Fundació Eurecat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785585
- Sponsor's protocol ID
- NORMB12
- Acronym
- NORMB12
- Status last verified
- Oct 2024
- First submitted
- 14 Mar 2023
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Methylcobalamin and Cyanocobalamin Consumption on Vitamin B12 Nutritional Status in Vegetarians With Marginal Vitamin B12 Deficiency. Randomized, Parallel, Placebo-Controlled, Triple-Blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT05785585
- Acronym / sponsor ID
- NORMB12 / NORMB12
- Conditions
- Vitamin B12 Nutritional Deficiency
- Keywords
- Vitamin B12, Methylcobalamin, Cyanocobalamin, Vegetarians, Holotranscobalamin, Methylmalonic acid, Homocysteine, 4cB12
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- Laboratorio Echevarne, Health Tech Bio Actives, S.L.U.
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin B12 (B12, Cobalamin) is an essential micronutrient that humans are not capable of synthesizing and therefore must be ingested through food. In nature, B12 is basically only present in foods of animal origin.
B12 deficiency is a clinically important condition that is associated with several metabolic disorders such as megaloblastic anemia, hyperhomocysteinemia, and cardiovascular, cerebrovascular, and neurological disorders. Therefore an optimal intake of B12 is important.
B12 deficiency occurs when B12 stores are depleted due to inadequate dietary intake or impaired absorption of B12. Because B12 is only present in foods of animal origin, following an unbalanced vegetarian diet is associated with increased risk of developing nutritional deficiencies due to the exclusion of meat and fish from their diet, including vitamin B12 deficiency.
There are a variety of forms of vitamin B12 used in vitamin B12 supplements. All these forms share the structure of Cobalamin but contain different ligands. Cyanocobalamin (CNCbl) is a synthetic, stable, and inexpensive form widely used in B12 supplements. MethylCobalamin (MeCbl) is a physiological form of cobalamin, called metabolically active form of vitamin B12. Interest in substituting CNCbl form with the physiological form MCbl has recently increased, assuming that it will be more effective.
The main objective of the study is to evaluate the effect of Methylcobalamin consumption, compared to Cyanocobalamin consumption, on the nutritional status of vitamin B12 in a vegetarian population with marginal vitamin B12 deficiency.
The secondary objectives of the study are to evaluate the effects of Methylcobalamin consumption, compared to Cyanocobalamin consumption, on markers of vitamin B12 deficiency: Holotranscobalamin, Methylmalonic acid, Homocysteine and 4cB12.
During the study there will be 8 visits: a preselection visit (V0; day -7) and 7 study visits during the consumption of the treatments, which will take place on the first day of the study (V1; day 1), after 8 days of treatment (V2; day 8), at 15 days of treatment (V3; day 15), at 29 days of treatment (V4; day 29), at 43 days of treatment (V5; day 43), at 64 days of treatment (V6; day 64), and at 85 days of treatment (V7; day 85).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methylcobalamin group | Experimental | Dietary Supplement: MethylcobalaminOne capsule daily with 500 µg of methylcobalamin for 12 weeks |
| Cyanocobalamin group | Active comparator | Dietary Supplement: Cyanocobalamin groupOne capsule daily with 500 µg of Cyanocobalamin for 12 weeks |
| Control group | Placebo comparator | Dietary Supplement: Control groupOne capsule daily with microcrystalline cellulose for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 18 years or older who follow a vegetarian diet.
- Present serum vitamin B12 levels of 148-221 pmol/L and absence of symptoms associated with vitamin B12 deficiency.
- Sign the informed consent.
- Read, write and speak Catalan or Spanish.
Key exclusion criteria (13 listed)
- Present diagnosed diseases that may interfere with vitamin B12 markers, including gastrointestinal diseases (such as inflammatory bowel disease, celiac disease, ileal resection, Crohn's disease, constipation or atrophic gastritis), pancreatic diseases, kidney diseases, liver diseases, diabetes, cardiovascular diseases, pernicious anemia and cancer.
- Medical history of abdominal surgery that may influence the absorption of vitamin B12 (such as bariatric surgery).
- Being on hemodialysis treatment.
- Present values of body mass index ≤ 18.5 kg/m^2 or ≥ 35 kg/m^2.
- Present anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylcobalaminTreatment with Methylcobalamin during 12 weeks | Dietary supplement | Methylcobalamin group |
| Cyanocobalamin groupTreatment with Cyanocobalamin during 12 weeks | Dietary supplement | Cyanocobalamin group |
| Control groupTreatment with microcrystalline cellulose during 12 weeks | Dietary supplement | Control group |
Primary outcome
Levels of total vitamin B12 in blood.
Time frame: At day -7 (pre-selection visit), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Serum total vitamin B12 will be measured by chemiluminescence immunoassay.
20 secondary outcomes
Levels of Holotranscobalamin in blood.
Time frame: At day -7 (pre-selection visit), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Levels of Methylmalonic acid in blood.
Time frame: At day -7 (pre-selection visit), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Levels of Homocysteine in blood.
Time frame: At day -7 (pre-selection visit), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Levels of 4cB12 marker.
Time frame: At day -7 (pre-selection visit), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Levels of folate in blood.
Time frame: At day -7 (pre-selection visit) and day 85 (visit 7).
Levels of vitamin B6 in blood.
Time frame: At day -7 (pre-selection visit) and day 85 (visit 7).
Health related quality of life.
Time frame: At day 1 (visit 1) and day 85 (visit 7).
Dietary habits and caloric intake.
Time frame: At day 1 (visit 1) and day 85 (visit 7).
Consumption of foods with vitamin B12.
Time frame: At day 1 (visit 1), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Compliance with dietary recommendations.
Time frame: At day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), and day 64 (visit 6).
Physical activity.
Time frame: At day 1 (visit 1) and day 85 (visit 7).
Concomitant medication.
Time frame: At day 1 (visit 1), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Consumption of food supplements.
Time frame: At day 1 (visit 1), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Body weight.
Time frame: At day 1 (visit 1) and day 85 (visit 7).
Height.
Time frame: At day -7 (pre-selection visit).
Body Mass Index.
Time frame: At day 1 (visit 1) and day 85 (visit 7).
Age.
Time frame: At day -7 (pre-selection visit).
Gender.
Time frame: At day -7 (pre-selection visit).
Intervention compliance.
Time frame: At day 43 (visit 5) and day 85 (visit 7).
Adverse events.
Time frame: At day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Caimari, PhD principal investigator
Fundació Eurecat
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylcobalamin and Cyanocobalamin group in people with Vitamin B12 Nutritional Deficiency, run by Fundació Eurecat at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoni Caimari, PhD (0034 977 300 431, antoni.caimari@eurecat.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of total vitamin B12 in blood. (time frame: At day -7 (pre-selection visit), day 8 (visit 2), day 15 (visit 3), day 29 (visit 4), day 43 (visit 5), day 64 (visit 6) and day 85 (visit 7).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.