Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.

Anemia Clinical Trial

Official title:

Validation of a Simple Questionnaire to Assess Gastrointestinal Symptoms After Oral Ferrous Sulphate Supplementation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146053
• Other study ID #: Symptoms KCL
• Status: Completed
• Phase: Early Phase 1
• First received: May 21, 2014
• Last updated: February 3, 2017
• Start date: March 2004
• Est. completion date: December 2004

Study information

• Verified date: February 2017
• Source: Medical Research Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Generally healthy subjects.

Exclusion Criteria:

• The presence of any chronic disease, pregnancy or lactation were considered as exclusion criteria.

Related Conditions & MeSH terms

• Abdominal Pain
• Anemia
• Constipation
• Diarrhea
• Heartburn
• Side Effect

Intervention

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.
• Placebo
placebo capsules: methyl cellulose

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Medical Research Council	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	14 days