- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02146053
Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.
Validation of a Simple Questionnaire to Assess Gastrointestinal Symptoms After Oral Ferrous Sulphate Supplementation.
Oral iron supplementation is often associated with rapid onset of gastrointestinal side-effects. The aim of this study was to develop and trial a short, simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating.
The study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out. Subjects were randomized into two treatment groups (n=10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron) or placebo, both to be taken at mealtimes twice daily during the treatment period. Subjects completed the questionnaires daily for 14 days. The questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e. nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
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London, United Kingdom
- King's College London
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Generally healthy subjects.
Exclusion Criteria:
- The presence of any chronic disease, pregnancy or lactation were considered as exclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ferrous sulfate
ferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period.
|
ferrous sulphate (200 mg capsules containing 65 mg of iron) to be taken at mealtimes twice daily for 7 days during the treatment period.
Other Names:
|
Placebo Comparator: Placebo
placebo taken at mealtimes twice daily during 1 week of the treatment period.
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placebo capsules: methyl cellulose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gastrointestinal symptoms
Time Frame: 14 days
|
Subjects completed the questionnaires daily for 14 days.
The questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e.
nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).
|
14 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Miranda Lomer, PhD, King's College London
- Study Chair: Jonathan Powell, PhD, MRC Human Nutrition Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Symptoms KCL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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