CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 440 enrolled
Drug / intervention
ferrous succinate and vitamin C +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02631668
NCT02631668Phase 4Completed

The Efficacy and Safety of Vitamin C for Iron Supplementation Therapy in Adult Patients With Iron Deficiency Anemia(IDA)

Huashan Hospital·interventional·Posted Dec 16, 2015·Updated Feb 25, 2019

In Brief

A Phase 4 clinical trial evaluating ferrous succinate and vitamin C and ferrous succinate for Anemia, Iron-Deficiency. Completed, enrolled 440 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 16, 2015
Enrollment StartJan 1, 2016
Primary CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 10.5 years ago

Interventions

ferrous succinate and vitamin Cdrug

As experimental group, when patients take the tablets of ferrous succinate, they also take vitamin C at the same time

ferrous succinatedrug

As active comparator, patients take the tablets of ferrous succinate with normal dosage in clinical practice

ferrous succinatedrug

As another active comparator, patients take the tablets of ferrous succinate with double dosage