Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.

Last updated: February 3, 2017
Sponsor: Medical Research Council
Overall Status: Completed

Phase

1

Condition

Constipation

Anemia

Colic

Treatment

N/A

Clinical Study ID

NCT02146053
Symptoms KCL
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Generally healthy subjects.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 20
Study Start date:
March 01, 2004
Estimated Completion Date:
December 31, 2004

Connect with a study center

  • King's College London

    London,
    United Kingdom

    Site Not Available

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