title: The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain.
abstract: 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.
authors.affiliation: Bahrain Defense Force Hospital/Royal Medical Services, Riffa, Bahrain.
authors.forename: Feryal
authors.initials: F
authors.lastname: Al-Saber
authors.affiliation: Bahrain Defense Force Hospital/Royal Medical Services, Riffa, Bahrain.
authors.forename: Waleed
authors.initials: W
authors.lastname: Aldosari
authors.affiliation: Bahrain Defense Force Hospital/Royal Medical Services, Riffa, Bahrain.
authors.forename: Mariam
authors.initials: M
authors.lastname: Alselaiti
authors.affiliation: Bahrain Defense Force Hospital/Royal Medical Services, Riffa, Bahrain.
authors.forename: Hesham
authors.initials: H
authors.lastname: Khalfan
authors.affiliation: Bahrain Defense Force Hospital/Royal Medical Services, Riffa, Bahrain.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Kaladari
authors.affiliation: SBI Pharmaceuticals Middle East and North Africa, Seef, Bahrain.
authors.forename: Ghulam
authors.initials: G
authors.lastname: Khan
authors.affiliation: DZS Clinical Services, Bound Brook, NJ, USA.
authors.forename: George
authors.initials: G
authors.lastname: Harb
authors.affiliation: SBI Pharmaceuticals Middle East and North Africa, Seef, Bahrain.
authors.forename: Riyadh
authors.initials: R
authors.lastname: Rehani
authors.affiliation: SBI Pharmaceuticals, Tokyo, Japan.
authors.forename: Sizuka
authors.initials: S
authors.lastname: Kudo
authors.affiliation: SBI Pharmaceuticals, Tokyo, Japan.
authors.forename: Aya
authors.initials: A
authors.lastname: Koda
authors.affiliation: SBI Pharmaceuticals, Tokyo, Japan.
authors.forename: Tohru
authors.initials: T
authors.lastname: Tanaka
authors.affiliation: SBI Pharmaceuticals, Tokyo, Japan.
authors.forename: Motowo
authors.identifier: 0000-0001-7687-6365
authors.initials: M
authors.lastname: Nakajima
authors.affiliation: Bahrain Defense Force Hospital/Royal Medical Services, Riffa, Bahrain.
authors.forename: Abdulla
authors.identifier: 0000-0002-9448-5867
authors.initials: A
authors.lastname: Darwish
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced; D000622:Aminolevulinic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D001445:Bahrain; D001786:Blood Glucose / Q000378:metabolism; D019343:Citric Acid; D003371:Cough / Q000139:chemically induced; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D005296:Ferrous Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000008:administration & dosage / Q000009:adverse effects; D010865:Pilot Projects; D016037:Single-Blind Method; D012964:Sodium / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000622:Aminolevulinic Acid; D001786:Blood Glucose; D019343:Citric Acid; D005296:Ferrous Compounds; D006442:Glycated Hemoglobin; D010710:Phosphates; D012964:Sodium; C517652:hemoglobin A1c protein, human; C016600:ferrous citrate