An interventional study of Methylcobalamin and Cyanocobalamin group in Vitamin B12 Nutritional Deficiency, sponsored by Fundació Eurecat. Recruiting at 2 sites in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Fundació Eurecat · Not applicable, Interventional, and Prevention
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).
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's planned enrollment of 54 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.
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Exclusion Criteria:
One capsule daily with 500 µg of methylcobalamin for 12 weeks
Dietary Supplement: Methylcobalamin
One capsule daily with 500 µg of Cyanocobalamin for 12 weeks
Dietary Supplement: Cyanocobalamin group
One capsule daily with microcrystalline cellulose for 12 weeks
Dietary Supplement: Control group
Treatment with Methylcobalamin during 12 weeks
Treatment with Cyanocobalamin during 12 weeks
Treatment with microcrystalline cellulose during 12 weeks
Levels of total vitamin B12 in blood.
Serum total vitamin B12 will be measured by chemiluminescence immunoassay.
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 Holotranscobalamin in blood.
Serum Holotranscobalamin will be measured by chemiluminescence immunoassay.
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.
Serum Methylmalonic acid will be measured by Liquid Chromatography coupled to tandem Mass Spectrometry.
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.
Plasma Homocysteine will be measured by Liquid Chromatography coupled to tandem Mass Spectrometry.
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.
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)).
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.
Serum folate will be measured by chemiluminescence immunoassay.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
The adherence to the dietary recommendations by the volunteers will be determined by analyzing the 24h dietary recall.
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.
Physical activity will be evaluated through the International Physical Activity Questionnaire (IPAQ)-short for physical activity questionnaire.
Time frame: 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.
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.
The consumption of food supplements by te volunteers will be controlled by the record of food supplements in the case report form.
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.
Body weight measured by standardized method.
Time frame: At day 1 (visit 1) and day 85 (visit 7).
Height.
Height measured by standardized method.
Time frame: At day -7 (pre-selection visit).
Body Mass Index.
Weight and height will be combined to report Body Mass Index in kg/m\^2.
Time frame: At day 1 (visit 1) and day 85 (visit 7).
Age.
The age of the volunteers will be recorded in the case report form.
Time frame: At day -7 (pre-selection visit).
Gender.
The gender of the volunteers will be recorded in the case report form.
Time frame: 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.
Time frame: 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.
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).
Plan to share: No
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