Normalization of vitamin B12 (B12) levels achieved following 1000 mcg oral Eligen® B12 therapy: A clinical study comparing the efficacy and safety of oral B12 therapy versus intramuscular (IM) therapy

Abstract

B12 deficiency occurs from dietary insufficiency or impaired absorption. The traditional treatment method is B12 IM injections. Oral B12 therapy is not considered dependable. Eligen® technology uses a functional excipient that increases and accelerates B12 uptake and more closely resembles B12 IM serum profile than other oral B12 formulations. This was an open‐label, randomized 90‐day study to assess the relative efficacy and safety of oral Eligen® B12 versus intramuscular B12 in promptly and reliably normalizing low B12 levels. The primary measurement was serum cobalamin (B12), the secondary measurements included methylmalonic acid and homocysteine. Holotranscobalamin was an exploratory endpoint. Blood samples were collected at Baseline, Day 15, Day 31, Day 61, and Day 91. A total of 49 patients were enrolled (26 IM and 23 oral). At the first time point (Day 15) all study parameters had returned to the normal range with both treatments. Normalization was maintained at all intervals up to and including Day 91. Eligen® B12 was well tolerated with no adverse drug related events. This study shows that oral Eligen B12 1000 mcg offers an alternative treatment option for patients requiring IM dosing.