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A Study to Compare the Gastrointestinal Tolerability of Ferrochel®, Sumalate®,Ferrous Fumarate, Ferrous Sulfate, Ferric Glycinate, and Placebo
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.
Details
| Lead sponsor | Albion |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 108 |
| Start date | 2014-04 |
| Completion | 2014-08 |
Conditions
- Anemia
Interventions
- Ferrochel® 90 mg
- Sumalate® 90 mg
- Ferrous fumarate 90 mg
- Ferrous Sulfate 90 mg
- Ferric Glycinate 90 mg
- Placebo
Primary outcomes
- Gastrointestinal questionnaire to measure the gastrointestinal tolerability — change from baseline in Gastrointestinal questionnaire on 7 days after the last dose of 30 days investigational product consumption
The gastrointestinal tolerability of the products will be assessed by self-assessment questionnaires and self-reported diaries at baseline (screening), day 0, day 15, day 30 of investigational product consumption, and 7 days after finished the investigational product.
Countries
Indonesia