CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Ferli-6® (Continental Pharm co., ltd.) +1 moredrug
Likely dose
Ferli-6® (Continental Pharm co., ltd.) 200 mgfrom 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/NCT00746551
NCT00746551Phase 4Completed

Low Dose Intravenous Versus Oral Iron for Iron Deficiency Anemia Starting Late in Pregnancy: A Randomized Controlled Trial

Mahidol University·interventional·Posted Sep 4, 2008·Updated Feb 16, 2015

In Brief

A Phase 4 clinical trial evaluating Ferli-6® (Continental Pharm co., ltd.) and Venofer® (Vifor AG, St. Gallen, Switzerland) for Anemia and Pregnancy Complications. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesThailand
CollaboratorsVifor Pharma

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 4, 2008
Enrollment StartSep 1, 2008
Primary CompletionMar 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.8 years ago

Interventions

Ferli-6® (Continental Pharm co., ltd.)drug

In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.

Venofer® (Vifor AG, St. Gallen, Switzerland)drug

Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.