Vitamin B 12 Deficiency
Conditions
Interventions
This is a phase IV, open-label, multicenter, prospective, paralell study with two treatment groups: Experimental group: you will receive treatment with Dozemast® (mecobalamin 1000 mcg), sublingually,
Sponsors
Loema - Instituto de Pesquisa Clínica e Consultores SS Ltda
Loema - Instituto de Pesquisa Clínica e Consultores SS Ltda
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes; aged between 18 and 65 years; who have the capacity to understand and agree to participate in the study, indicating by signing the Free and Informed Consent Form approved by the Research Ethics Committee System; and agreeing to comply with the planned study procedures and to attend the visits; will be included in the study must be vitamin B12 deficient (serum cobalamin dosage < 300 pg/mL), good health, determined by the absence of significant findings in medical history, physical examination, laboratory tests (biochemistry, hematology, and urinalysis), measurement of vital signs, and electrocardiogram results; participants who do not have reproductive potential should be checked for their current condition, such as: postmenopausal women (defined as 12 months or more of amenorrhea), hysterectomized women, oophorectomized women (bilateral) and/or have undergone tubal ligation (tubal ligation); the female participants must have childbearing potential who present a negative pregnancy test result on the day of administration of the first dose of the drugs of the study, as well as throughout the clinical trial; and agree on the use of safe contraception
Exclusion criteria
Exclusion criteria: Participants who have any clinical condition that, at the discretion of the investigator, may compromise participation in the study, and/or have difficulty swallowing solid medications; have a diagnosis of pernicious anemia or documented or suspected hemoglobinopathies; have a diagnosis of gastrointestinal disease that compromises the absorption of vitamin B12 administered orally (atrophic gastritis or Crohn's disease); have undergone bariatric surgery (partial or complete gastrectomy, or gastric reduction surgery); have undergone ileal resection or pancreaticopancreatical; have a documented or suspected diagnosis of pancreatic disease; or have undergone pancreatectomy; have undergone oral treatment with vitamin B12 (mecobalamin, hydroxycobalamin or cyanocobalamin) and/or multivitamins containing vitamin B12 in the last 30 days; or have been treated with injectable formulations containing vitamin B12 in the last 3 months; have chronic liver disease (documented or suspected) or current laboratory abnormality of liver enzymes; have chronic kidney injury requiring dialysis; have a history of myeloproliferative diseases or other neoplastic/metastatic diseases in the last 5 years; use levodopa, phenobarbital, phenytoin, primidone, pyrimethamine, valproic acid, hydantoin, aminosalicylates, aminoglycosides, colchicine, potassium in extended-release formulation, mesalazine, ascorbic acid, antibiotics, nitrates, fluorouracil, chloramphenicol, proton inhibitors, metformin, and biotin (vitamin B7); have a history of alcoholism (average alcohol intake of more than 3 drinks of alcoholic beverages in one day or more than 7 drinks of alcoholic beverages per week, for women, and more than 4 drinks of alcoholic beverages in one day or more than 14 drinks of alcoholic beverages per week, for men); or having ingested alcoholic beverages in the last week prior to the start of treatment; have a folate deficiency and/or having an iron deficiency; if the participant is pregnant, breastfeeding and/or intends to become pregnant during the study period; have hypersensitivity or contraindication to use of study drugs or chemically related compounds; have participated in clinical studies in the past twelve (12) months, unless there may be direct benefit to the research participant, at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alteration in serum vitamin B12 level after two months of treatment, in relation to baseline, between the investigational drug and comparator, through the results obtained in laboratory tests | — |
Secondary
| Measure | Time frame |
|---|---|
| Alteration of serum levels of holotranscobalamin and methylmalonic acid after two months of treatment, in relation to the baseline value, between the investigational drug and the comparator, through the results obtained in the laboratory tests.;Rate of occurrence of non-serious and serious, related and non-investigational products adverse events over the course of the clinical study | — |
Countries
Brazil
Contacts
Public ContactCristiane Lima
Marjan Indústria e Comércio Ltda
Outcome results
None listed