drugset / Trial / NCT02631668

the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients

NCT02631668

Phase 4 Completed 440 enrolled Huashan Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

IDA patients ofen receive ferrous succinate treatment to speed up the recovery of anemia, the doctor will prescribe ferrous succinate with or without vitamin C according to their own preferences. In theory, only the divalent iron can be absorbed in duodenum and upper jejunum, vitamin C can oxidize ferric iron into divalent iron and maintains a certain degree of acidity in the intestine, and then promotes the absorption of iron. In current clinical practice, it's lack of randomized controlled trial(RCT) about the efficacy and safety of vitamin C for iron supplementation in patients with IDA. In this study, the efficacy and safety of vitamin C for iron supplementation in adult IDA patients are explored by RCT. The dosage regimens of ferrous succinate with or without vitamin C are randomly assigned to patients who meet the inclusion criteria, and these patients are followed up every two weeks. On the one hand, whether the addition of vitamin C can accelerate the recovery of anemia is evaluated, on the other hand, whether the addition of vitamin C can increase the incidence of gastrointestinal tract discomfort is aslo appraised , the discomfort include vomiting, nausea, abdominal pain, diarrhea and constipation. We hypothesis that vitamin C can increase the absorption of iron and accelerate the recovery of anemia, it also increases incidence of gastrointestinal adverse events because of increased iron absorption at the same time.

Timeline

Start
2016-01-01
Primary completion
2018-12-31
Completion
2018-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferrous Sulfate Diagnostic / imaging agent 100 mg Oral
Comparator Ferrous Sulfate Diagnostic / imaging agent 200 mg Oral
Subject Vitamin C Other / unclassified 200 mg