Effect of Methylcobalamin and Cyanocobalamin Consumption on Vitamin B12 Nutritional Status

NCT05785585 | Recruiting

• 1 other identifier: NORMB12
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Vitamin B12 Nutritional Deficiency

Keywords

Vitamin B12; Methylcobalamin; Cyanocobalamin; Vegetarians; Holotranscobalamin; Methylmalonic acid; Homocysteine; 4cB12

Outcome Measures

Primary Outcomes (1)

• Levels of total vitamin B12 in blood.

  Serum total vitamin B12 will be measured by chemiluminescence immunoassay.

  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.

  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.

  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.

  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.

  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.

  At day -7 (pre-selection visit) and day 85 (visit 7).

Study Arms (3)

Methylcobalamin group

EXPERIMENTAL

One capsule daily with 500 µg of methylcobalamin for 12 weeks

Dietary Supplement: Methylcobalamin

Cyanocobalamin group

ACTIVE COMPARATOR

One capsule daily with 500 µg of Cyanocobalamin for 12 weeks

Dietary Supplement: Cyanocobalamin group

Control group

PLACEBO COMPARATOR

One capsule daily with microcrystalline cellulose for 12 weeks

Dietary Supplement: Control group

Interventions

Methylcobalamin DIETARY_SUPPLEMENT

Treatment with Methylcobalamin during 12 weeks

Methylcobalamin group

Cyanocobalamin group DIETARY_SUPPLEMENT

Treatment with Cyanocobalamin during 12 weeks

Cyanocobalamin group

Control group DIETARY_SUPPLEMENT

Treatment with microcrystalline cellulose during 12 weeks

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Fundació Eurecat: lead
• Laboratorio Echevarne: collaborator
• Health Tech Bio Actives, S.L.U.: collaborator

Study Sites (2)

Fundació Eurecat

Reus, Tarragona, 43204, Spain

RECRUITING

Eurecat

Reus, 43204, Spain

RECRUITING

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus.

MeSH Terms

Interventions

mecobalamin; Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Antoni Caimari, PhD

  Fundació Eurecat

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoni Caimari, PhD

CONTACT

0034 977 300 431; antoni.caimari@eurecat.org

Anna Crescenti

CONTACT

0034 977 300 431; anna.crescenti@eurecat.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Eurecat's Biotechnology Area, Principal Investigator

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: September 9, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)