A Study to Compare the Gastrointestinal Tolerability of Ferrochel®, Sumalate®,Ferrous Fumarate, Ferrous Sulfate, Ferric Glycinate, and Placebo
1 other identifier
interventional
108
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 21, 2014
CompletedFirst Posted
Study publicly available on registry
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMay 6, 2014
May 1, 2014
2 months
April 21, 2014
May 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastrointestinal questionnaire to measure the gastrointestinal tolerability
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.
change from baseline in Gastrointestinal questionnaire on 7 days after the last dose of 30 days investigational product consumption
Secondary Outcomes (3)
the laboratory result to measure the change from baseline
up to 30 days of investigational product consumption
the laboratory result to measure the change from baseline
up to 30 days of investigational product consumption
the laboratory result to measure the change from baseline
up to 30 days of investigational product consumption
Study Arms (6)
Ferrochel® 90 mg
ACTIVE COMPARATORFerrochel® capsule 90 mg OD for 30 days
Sumalate® 90 mg
ACTIVE COMPARATORSumalate® capsule 90 mg OD for 30 days
Ferrous Fumarate 90 mg
ACTIVE COMPARATORFerrous Fumarate capsule 90 mg OD for 30 days
Ferrous Sulfate 90 mg
ACTIVE COMPARATORFerrous Sulfate capsule 90 mg OD for 30 days
Ferric glycinate 90 mg
ACTIVE COMPARATORFerric glycinate capsule 90 mg OD for 30 days
Placebo
ACTIVE COMPARATORPlacebo capsule OD for 30 days
Interventions
Ferrochel® capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
Sumalate® capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
Ferrous fumarate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
Ferrous Sulfate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
Ferric Glycinate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
Placebo capsule, administered orally once daily in the morning after breakfast, for 30 days
Eligibility Criteria
You may qualify if:
- Women, 18-50 years of age, inclusive
- Hemoglobin 8 g/dl - 11 g/dl
- Ferritin levels \< 20 mcg/l (20 ng/mL)
- Subject, or subject's acceptable representative, has voluntarily signed and dated an informed consent form, approved by a local Ethics Committee/Institutional Review Board prior to any participation in the study
You may not qualify if:
- Pregnant or lactating
- Amenorrhea
- Severe anemia (hemoglobin 7 g/dl) or other blood abnormality (e.g., leukopenia, thrombocytopenia, polycythemia vera)
- Serious illness that may confound study results or interfere with compliance
- Subjects that have followed specific diet, eg. high protein diet, within 30 days prior to study start
- Subjects that have taken iron supplements within 30 days prior to study start
- Subjects that are allergic to any of the ingredients in the products
- Participation in other clinical trials within three months prior to screening
- Known intolerance to oral iron supplements
- Habitual smokers (more than 3 cigarettes per week)
- Other medical conditions that, in the investigator's opinion, may confound study results or prelude the subject's ability to safely complete the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Albionlead
- Sprim Advanced Life Sciencescollaborator
Study Sites (1)
Laboratory Faculty of Pharmacy, Universitas Indonesia
Depok, West Java, 16424, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yahdiana Harahap, Professor
Laboratory Faculty of Pharmacy, Universitas Indonesia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2014
First Posted
May 1, 2014
Study Start
April 1, 2014
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
May 6, 2014
Record last verified: 2014-05