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A Study to Compare the Gastrointestinal Tolerability of Ferrochel®, Sumalate®,Ferrous Fumarate, Ferrous Sulfate, Ferric Glycinate, and Placebo

NCT02128971 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2014-05-06

No results posted yet for this study

Summary

The purpose of this study is to compare the gastrointestinal (GI) tolerability of 5 different iron supplements (Ferrochel®, Sumalate®,ferrous fumarate, ferrous sulfate and ferric glycinate) at the same dose (90mg) and placebo.

Conditions

Interventions

DIETARY_SUPPLEMENT

Ferrochel® 90 mg

Ferrochel® capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days

DIETARY_SUPPLEMENT

Sumalate® 90 mg

Sumalate® capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days

DIETARY_SUPPLEMENT

Ferrous fumarate 90 mg

Ferrous fumarate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days

DIETARY_SUPPLEMENT

Ferrous Sulfate 90 mg

Ferrous Sulfate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days

DIETARY_SUPPLEMENT

Ferric Glycinate 90 mg

Ferric Glycinate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days

DIETARY_SUPPLEMENT

Placebo

Placebo capsule, administered orally once daily in the morning after breakfast, for 30 days

Sponsors & Collaborators

  • Sprim Advanced Life Sciences

    collaborator OTHER

  • Albion

    lead INDUSTRY

Principal Investigators

  • Yahdiana Harahap, Professor · Laboratory Faculty of Pharmacy, Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-06-30
Completion
2014-08-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

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 NCT02128971 on ClinicalTrials.gov