[A randomized controlled and multicenter clinical study of ferrous L-threonate in treatment of iron deficiency anemia]

Abstract

Objective: To study the clinical efficacy and side effects of ferrous L-threonate for treatment of iron deficiency anemia (IDA).

Methods: It is a multicentral, randomized, double blind, double placebo and paralled comparative study with positive control. One hundred and forty IDA patients diagnosed according to the standard criteria in three hospitals were randomly divided into a test group (ferrous L-threonate plus placebo ferrous succinate) and a positive control group (ferrous succinate plus placebo ferrous L-threonate). Some iron parameters were examined 1, 4 and 8 weeks after medication. Hemoglobin, reticulocyte and other parameters for safety observation were collected every two weeks.

Results: For the 2 groups, self comparison showed significant difference (P < 0.01). The total efficacy is 98.44% and 97.01% respectively with no difference. Hemoglobin rised rapidly and gradually and reached a peak in week 8, the change was statistically significant (P < 0.01). Changes of iron parameters also showed significant difference. Side-effects were similar in both groups (13.85% and 14.71%, P > 0.05).

Conclusion: The effect of ferrous L-threonate in IDA treatment is significant and rapid. Side-effects are few and minimal.