The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain
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 prospectiv...
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| Format: | Article |
| Language: | English |
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Wiley
2016-01-01
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| Series: | Journal of Diabetes Research |
| Online Access: | http://dx.doi.org/10.1155/2016/8294805 |
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| author | Feryal Al-Saber Waleed Aldosari Mariam Alselaiti Hesham Khalfan Ahmed Kaladari Ghulam Khan George Harb Riyadh Rehani Sizuka Kudo Aya Koda Tohru Tanaka Motowo Nakajima Abdulla Darwish |
| author_facet | Feryal Al-Saber Waleed Aldosari Mariam Alselaiti Hesham Khalfan Ahmed Kaladari Ghulam Khan George Harb Riyadh Rehani Sizuka Kudo Aya Koda Tohru Tanaka Motowo Nakajima Abdulla Darwish |
| author_sort | Feryal Al-Saber |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-5344042ef400427089bf876e7daca7f3 |
| institution | Kabale University |
| issn | 2314-6745 2314-6753 |
| language | English |
| publishDate | 2016-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Diabetes Research |
| spelling | doaj-art-5344042ef400427089bf876e7daca7f32025-02-03T05:46:27ZengWileyJournal of Diabetes Research2314-67452314-67532016-01-01201610.1155/2016/82948058294805The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in BahrainFeryal Al-Saber0Waleed Aldosari1Mariam Alselaiti2Hesham Khalfan3Ahmed Kaladari4Ghulam Khan5George Harb6Riyadh Rehani7Sizuka Kudo8Aya Koda9Tohru Tanaka10Motowo Nakajima11Abdulla Darwish12Bahrain Defense Force Hospital/Royal Medical Services, Riffa, BahrainBahrain Defense Force Hospital/Royal Medical Services, Riffa, BahrainBahrain Defense Force Hospital/Royal Medical Services, Riffa, BahrainBahrain Defense Force Hospital/Royal Medical Services, Riffa, BahrainBahrain Defense Force Hospital/Royal Medical Services, Riffa, BahrainSBI Pharmaceuticals Middle East and North Africa, Seef, BahrainDZS Clinical Services, Bound Brook, NJ, USASBI Pharmaceuticals Middle East and North Africa, Seef, BahrainSBI Pharmaceuticals, Tokyo, JapanSBI Pharmaceuticals, Tokyo, JapanSBI Pharmaceuticals, Tokyo, JapanSBI Pharmaceuticals, Tokyo, JapanBahrain Defense Force Hospital/Royal Medical Services, Riffa, BahrainType 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.http://dx.doi.org/10.1155/2016/8294805 |
| spellingShingle | Feryal Al-Saber Waleed Aldosari Mariam Alselaiti Hesham Khalfan Ahmed Kaladari Ghulam Khan George Harb Riyadh Rehani Sizuka Kudo Aya Koda Tohru Tanaka Motowo Nakajima Abdulla Darwish The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain Journal of Diabetes Research |
| title | The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain |
| title_full | The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain |
| title_fullStr | The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain |
| title_full_unstemmed | The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain |
| title_short | The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain |
| title_sort | safety and tolerability of 5 aminolevulinic acid phosphate with sodium ferrous citrate in patients with type 2 diabetes mellitus in bahrain |
| url | http://dx.doi.org/10.1155/2016/8294805 |
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