Safety of Oral Administration of 5-Aminolevulinic Acid Phosphate Combined with Ferrous Iron in Healthy Subjects: An Open-Label Trial by Fumiko Higashikawa Hidenori Ito & Tohru Tanaka

Author:Fumiko Higashikawa, Hidenori Ito & Tohru Tanaka
Format: pdf
Tags: The combination of 5-aminolevulinic acid (5-ALA) phosphate and sodium ferrous citrate (SFC) has been approved as an ingredient in dietary supplements in several countries, owing to its broad applicability in healthcare. This study aimed to assess the safety of oral administration of 5-ALA and SFC in healthy adults at doses several times higher than those commercially available. This study included 22 healthy subjects (11 males and 11 females) aged 21–59. Doses of 250 mg 5-ALA phosphate and 143.4 mg SFC (15 mg Fe) per day were administered orally for 28 days. Blood tests, urinalysis, and medical interviews were performed to assess safety. No test compound-related adverse events or abnormal changes were observed, except for elevated serum Fe levels, which were mild-to-moderate and transient. In conclusion, the combined oral administration of 5-ALA phosphate and SFC in healthy adults was safe and well-tolerated at the dose and duration investigated in this study., 5-aminolevulinic acid; sodium ferrous citrate; safety; iron; dietary supplement


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