A Post-Marketing Survey Study on Effects of 5-Aminolevulinic Acid Phosphate/ Sodium Ferrous Citrate Supplement on Patients with Type 2 Diabetes Mellitus in Bahrain

The primary objective of this study was to assess the safety and benefits of a nutritional supplement containing 100 mg of 5-aminolevulinic acid phosphate and 29 mg of sodium ferrous citrate (5-ALA phosphate/SFC) in patients with diabetes when administered in conjunction with standard-of-care hypoglycemic treatment. This post-marketing surveillance (PMS) study included 100 male and female diabetic patients from 14 healthcare centers in Bahrain, all of whom received 5-ALA phosphate/SFC in addition to their routine diabetes medications. Outcomes were compared with data from 96 historical control patients who received standard-of-care treatment alone. Data were collected at 16-week intervals: pre-study (t0–16 weeks), at treatment initiation (t0), at the end of treatment (t0+16 weeks), and at post-treatment follow-up (t0+32 weeks). Adverse events reported were either mild or unrelated to the supplement. Patients receiving 5-ALA phosphate/SFC were categorized into four response classes based on changes in HbA1c levels: super-responders, responders, steady-responders, and non-responders. Statistically significant reductions in HbA1c were observed in both the super-responder and responder classes at post-treatment follow-up (p < 0.05). No abnormalities were noted in blood laboratory analyses post-treatment. Among non-responders, insulin was administered when oral hypoglycemic agents proved ineffective due to severe insulin resistance. The findings suggest that 5-ALA phosphate/SFC is a safe and effective adjunct oral hypoglycemic supplement when used with standard-of-care treatments for diabetes. It was postulated that 5-ALA phosphate/SFC upregulates mitochondrial function. A follow-up study was also conducted to evaluate the supplement’s potential effect on mitochondrial activity, a factor often impaired in insulin-resistant individuals, particularly among super-responders. Further randomized, double-blind, placebo-controlled trials are warranted to confirm these findings.