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

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ClinicalTrials.gov Identifier: NCT02128971
Recruitment Status : Unknown
Verified May 2014 by Albion.
Recruitment status was:  Recruiting
First Posted : May 1, 2014
Last Update Posted : May 6, 2014
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Albion

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.

Condition or disease Intervention/treatment Phase
Anemia Dietary Supplement: Ferrochel® 90 mg Dietary Supplement: Sumalate® 90 mg Dietary Supplement: Ferrous fumarate 90 mg Dietary Supplement: Ferrous Sulfate 90 mg Dietary Supplement: Ferric Glycinate 90 mg Dietary Supplement: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Compare the Gastrointestinal Tolerability of Ferrochel®, Sumalate®,Ferrous Fumarate, Ferrous Sulfate, Ferric Glycinate, and Placebo
Study Start Date : April 2014
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ferrochel® 90 mg
Ferrochel® capsule 90 mg OD for 30 days
Dietary Supplement: Ferrochel® 90 mg
Ferrochel® capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
Other Name: Ferrous Bisglycinate

Active Comparator: Sumalate® 90 mg
Sumalate® capsule 90 mg OD for 30 days
Dietary Supplement: Sumalate® 90 mg
Sumalate® capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
Other Name: Ferrous aspartoglycinate

Active Comparator: Ferrous Fumarate 90 mg
Ferrous Fumarate capsule 90 mg OD 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

Active Comparator: Ferrous Sulfate 90 mg
Ferrous Sulfate capsule 90 mg OD 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

Active Comparator: Ferric glycinate 90 mg
Ferric glycinate capsule 90 mg OD 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

Active Comparator: Placebo
Placebo capsule OD for 30 days
Dietary Supplement: Placebo
Placebo capsule, administered orally once daily in the morning after breakfast, for 30 days




Primary Outcome Measures :
  1. Gastrointestinal questionnaire to measure the gastrointestinal tolerability [ Time Frame: 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.


Secondary Outcome Measures :
  1. the laboratory result to measure the change from baseline [ Time Frame: up to 30 days of investigational product consumption ]
    hemoglobin levels of each subject will be measured at baseline (screening), day 0, day 15 and day 30 of investigational product consumption

  2. the laboratory result to measure the change from baseline [ Time Frame: up to 30 days of investigational product consumption ]
    Hematocrit levels of each subject will be measured at baseline (screening), day 0, day 15 and day 30 of investigational product consumption

  3. the laboratory result to measure the change from baseline [ Time Frame: up to 30 days of investigational product consumption ]
    Ferritin levels of each subject will be measured at baseline (screening), day 0, day 15 and day 30 of investigational product consumption



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women, 18-50 years of age, inclusive
  2. Hemoglobin 8 g/dl - 11 g/dl
  3. Ferritin levels < 20 mcg/l (20 ng/mL)
  4. 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

Exclusion Criteria:

  1. Pregnant or lactating
  2. Amenorrhea
  3. Severe anemia (hemoglobin 7 g/dl) or other blood abnormality (e.g., leukopenia, thrombocytopenia, polycythemia vera)
  4. Serious illness that may confound study results or interfere with compliance
  5. Subjects that have followed specific diet, eg. high protein diet, within 30 days prior to study start
  6. Subjects that have taken iron supplements within 30 days prior to study start
  7. Subjects that are allergic to any of the ingredients in the products
  8. Participation in other clinical trials within three months prior to screening
  9. Known intolerance to oral iron supplements
  10. Habitual smokers (more than 3 cigarettes per week)
  11. Other medical conditions that, in the investigator's opinion, may confound study results or prelude the subject's ability to safely complete the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128971


Contacts
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Contact: Eka Windari Rusman +62 21 83701201 eka.windari@sprim.com
Contact: Jennifer Hartle 8017734631 jhartle@albionminerals.com

Locations
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Indonesia
Laboratory Faculty of Pharmacy, Universitas Indonesia Recruiting
Depok, West Java, Indonesia, 16424
Contact: Yahdiana Harahap, Professor    +62-21-7270031    yahdiana.ms@ui.ac.id   
Sponsors and Collaborators
Albion
Sprim Advanced Life Sciences
Investigators
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Principal Investigator: Yahdiana Harahap, Professor Laboratory Faculty of Pharmacy, Universitas Indonesia

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Responsible Party: Albion
ClinicalTrials.gov Identifier: NCT02128971     History of Changes
Other Study ID Numbers: AM-FEB-INDO-2013-01
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Keywords provided by Albion:
Iron supplement study
Additional relevant MeSH terms:
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Ferrous fumarate
Glycine
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action