Comparing the Safety and Effectiveness of Injected Vitamin B6, B12, and Folic Acid Combination Versus Oral Vitamin B12 for Treating Vitamin B12 Deficiency

What this Trial Is About

Researchers are evaluating the effects of a parenteral vitamin B12 combination treatment versus an oral vitamin B12 monotherapy on vitamin B12 status in adults with vitamin B12 deficiency. The study aims to compare changes in serum vitamin B12 concentration after 4 weeks of treatment, along with other markers such as holotranscobalamin, homocysteine, methylmalonic acid, and quality of life measures. Safety and tolerability of both treatments are also being assessed in this Phase 4 trial sponsored by Medice Arzneimittel Ptter GmbH & Co KG. Participants are randomly assigned to receive either the vitamin injection or oral vitamin B12 tablets. The injection group receives 1 intramuscular injection twice weekly at the clinical site, totaling 8 injections over 4 weeks. The oral group takes one tablet daily in the morning for 28 days. The vitamin injection contains a fixed combination of vitamin B6, B12, and folic acid, while the oral treatment consists of vitamin B12 tablets. During the study, participants undergo assessments of various blood markers at baseline, day 28, and follow-up at day 56. These include vitamin B12, holotranscobalamin, homocysteine, methylmalonic acid, combined vitamin B12 markers, and serum levels of related compounds. Quality of life is evaluated using questionnaires such as WHO-5, SF-36, and VAS EQ-5D. Safety and tolerability are monitored throughout. The total participation duration includes a 4-week treatment period followed by a safety follow-up at day 56.

A Study to See if a Combination of Vitamins That is Injected Into a Muscle is as Good and Safe as a Vitamin That is Taken by Mouth