MedTrace Logo

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

NCT02631668 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2019-02-25

No results posted yet for this study

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.

Conditions

  • Anemia, Iron-Deficiency

Interventions

DRUG

ferrous succinate and vitamin C

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

DRUG

ferrous succinate

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

DRUG

ferrous succinate

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

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Qin X Wang, doctorate · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02631668 on ClinicalTrials.gov