5-Aminolevulinic Acid Phosphate as an Immune System Enhancer Along with Vaccination Against SARS-CoV-2 Virus Infection: An Open-Label, Randomized Pilot Study

It is known from former publications that the study product, 5-Aminolevulinic acid (5-ALA) phosphate together with sodium ferrous citrate (SFC), which is marketed as food supplement, appears to be an important metabolic regulator in depleted T-cell metabolism. Therefore, it was hypothesized that its administration in subjects vaccinated against COVID-19 could enhance their immune system. Therefore, the aim of our proof-of-concept study was to determine the safety (by adverse events (AE) monitoring), the tolerability (by patient questionnaires) and to investigate immune-boosting properties (by Immunoglobulins) in which 200 subjects were randomized in a ratio of 1:1 within 2 arms. In the intervention arm the study product was administered together with the vaccines Covishield or Covaxin, and up to 21 days thereafter with a 150 mg daily dose whereas in the control arm the subjects were vaccinated only. No safety issues were detected from the AE profile and the evaluation of the subject questionnaires showed no limitation of the well-being, which confirms the excellent tolerability of 5-ALA-phosphate + SFC. Moreover, the ‘Change in Immunoglobulin G levels’, although statistically insignificant, showed strong signals of its immune supportive potential. However, further studies are recommended to verify the results.