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Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.

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ClinicalTrials.gov Identifier: NCT02146053
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
dora pereira, Medical Research Council

Study Description
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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).


Condition or disease Intervention/treatment Phase
Anemia Constipation Diarrhea Abdominal Pain Heartburn Side Effect Dietary Supplement: ferrous sulfate Dietary Supplement: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Validation of a Simple Questionnaire to Assess Gastrointestinal Symptoms After Oral Ferrous Sulphate Supplementation.
Study Start Date : March 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ferrous sulfate
ferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period.
 Dietary Supplement: ferrous sulfate
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 Name: ferrous sulphate
Placebo Comparator: Placebo
placebo taken at mealtimes twice daily during 1 week of the treatment period.
 Dietary Supplement: Placebo
placebo capsules: methyl cellulose


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Generally healthy subjects.

Exclusion Criteria:

  • The presence of any chronic disease, pregnancy or lactation were considered as exclusion criteria.
Contacts and Locations
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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): NCT02146053


Locations
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United Kingdom
King's College London
London, United Kingdom
Sponsors and Collaborators
Medical Research Council
King's College London
Investigators
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Principal Investigator: Miranda Lomer, PhD King's College London
Study Chair: Jonathan Powell, PhD MRC Human Nutrition Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: dora pereira, Dr, Medical Research Council
ClinicalTrials.gov Identifier: NCT02146053    
Other Study ID Numbers: Symptoms KCL
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Keywords provided by dora pereira, Medical Research Council:
healthy participants
gastrointestinal side-effects associated with oral iron
Additional relevant MeSH terms:
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Constipation
Diarrhea
Abdominal Pain
Heartburn
 Signs and Symptoms, Digestive
Pain
Neurologic Manifestations