EFFICACY AND SAFETY OF A PARENTERALLY ADMINISTERED FIXED VITAMIN COMBINATION (VITAMIN B6, B12 AND FOLIC ACID) ON VITAMIN B12 STATUS AND METHYLATION CAPACITY IN COBALAMIN DEFICIENCY COMPARED TO ORAL VITAMIN B12 SUPPLEMENTATION - EASYVit

MEDICE Arzneimittel Pütter GmbH & Co. KG0 个研究点目标入组 40 人开始时间: 2019年10月8日最近更新: 2024年6月10日

适应症

试验速览

暂无简介。

•Provision of written informed consent to participate in the study (according to AMG §40 (1)3b).
•Female and male patients aged =18.
•Diagnosis of vitamin B12 deficiency, defined as serum vitamin B12 < 350 pmol/L.
•Female patients of childbearing potential (WOCBP) must be using two acceptable methods of contraception
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Active or recent vitamin B12 intake (the subject must not receive vitamin B12 drugs or food supplements for at least 6 months).
•Participation in a previous clinical study with vitamin B12 within the 6 months prior to screening.
•Any contraindication to one of the study drugs.
•Pregnant or nursing (lactating) women.
•Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
•Subjects with anemia (haemoglobin < 10 mg/dL) or neurological symptoms due to vitamin B12 deficiency.
•Any diseases that prevent intrinsic-factor independent passive diffusion in the small intestine (e.g. ileum resection)
•Current drug addiction and/or alcohol abuse as evidenced by patient history and/or as determined by the investigator at V-1.
•Cognitive or behavioral abnormalities that could impair the capacity to give informed consent or carry out protocol-specified procedures.
•Inability to take oral medication

发起方