The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain

Abstract EN

Type 2 diabetes mellitus is prevalent especially in Gulf countries and poses serious long-term risks to patients.

A multifaceted treatment approach can include nutritional supplements with antioxidant properties such as 5-aminolevulinic acid (5-ALA) with sodium ferrous citrate (SFC).

This prospective, randomized, single-blind, placebo-controlled, dose escalating pilot clinical trial assessed the safety of 5-ALA with SFC at doses up to 200 mg 5-ALA/229.42 mg SFC per day in patients living in Bahrain with type 2 diabetes mellitus that was uncontrolled despite the use of one or more antidiabetic drugs.

Fifty-three patients (n=53) from 3 sites at one center were enrolled by Dr.

Feryal (Site #01), Dr.

Hesham (Site #02), and Dr.

Waleed (Site #03) (n=35, 5-ALA-SFC; n=18, placebo).

There was no significant difference in incidence of adverse events reported, and the most frequent events reported were gastrointestinal in nature, consistent with the known safety profile of 5-ALA in patients with diabetes.

No significant changes in laboratory values and no difference in hypoglycemia between patients receiving 5-ALA and placebo were noted.

Overall, the current results support that use of 5-ALA-SFC up to 200 mg per day taken as 2 divided doses is safe in patients taking concomitant oral antidiabetic medications and may offer benefits in the diabetic population.

This trial is registered with ClinicalTrials.gov NCT02481141.