Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.

Early Phase 1

Completed

• Conditions: Anemia; Heartburn; Constipation; Diarrhea; Abdominal Pain; Side Effect
• Interventions: Dietary Supplement: ferrous sulfate; Dietary Supplement: Placebo

• Registration Number: NCT02146053
• Lead Sponsor: Medical Research Council

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-23
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Generally healthy subjects.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferrous sulfate	ferrous sulfate	ferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period.
Placebo	Placebo	placebo taken at mealtimes twice daily during 1 week of the treatment period.

Primary Outcome Measures

Name	Time	Method
gastrointestinal symptoms	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).

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, United Kingdom