Back to resultsQuestionnaire to Assess Gastrointestinal Symptoms of Oral Iron.
Primary Purpose
Anemia, Constipation, Diarrhea
Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
ferrous sulfate
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Anemia focused on measuring healthy participants, gastrointestinal side-effects associated with oral iron
Eligibility Criteria
Inclusion Criteria:
- Generally healthy subjects.
Exclusion Criteria:
- The presence of any chronic disease, pregnancy or lactation were considered as exclusion criteria.
Sites / Locations
- King's College London
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ferrous sulfate
Placebo
Arm Description
ferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period.
placebo taken at mealtimes twice daily during 1 week of the treatment period.
Outcomes
Primary Outcome Measures
gastrointestinal symptoms
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02146053
First Posted
May 21, 2014
Last Updated
February 3, 2017
Sponsor
Medical Research Council
Collaborators
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT02146053
Brief Title
Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.
Official Title
Validation of a Simple Questionnaire to Assess Gastrointestinal Symptoms After Oral Ferrous Sulphate Supplementation.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Research Council
Collaborators
King's College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Constipation, Diarrhea, Abdominal Pain, Heartburn, Side Effect
Keywords
healthy participants, gastrointestinal side-effects associated with oral iron
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferrous sulfate
Arm Type
Active Comparator
Arm Description
ferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo taken at mealtimes twice daily during 1 week of the treatment period.
Intervention Type
Dietary Supplement
Intervention Name(s)
ferrous sulfate
Other Intervention Name(s)
ferrous sulphate
Intervention Description
ferrous sulphate (200 mg capsules containing 65 mg of iron) to be taken at mealtimes twice daily for 7 days during the treatment period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
placebo capsules: methyl cellulose
Primary Outcome Measure Information:
Title
gastrointestinal symptoms
Description
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).
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Generally healthy subjects.
Exclusion Criteria:
The presence of any chronic disease, pregnancy or lactation were considered as exclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miranda Lomer, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Powell, PhD
Organizational Affiliation
MRC Human Nutrition Research
Official's Role
Study Chair
Facility Information:
Facility Name
King's College London
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24899360
Citation
Pereira DI, Couto Irving SS, Lomer MC, Powell JJ. A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation. BMC Gastroenterol. 2014 Jun 4;14:103. doi: 10.1186/1471-230X-14-103.
Results Reference
derived
Learn more about this trial
Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.
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