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Completed

NCT Number: NCT02146053

Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.

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).

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Key information

Conditions

Anemia Abdominal Pain Constipation Diarrhea Heartburn Hematologic Diseases Hemic and Lymphatic Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Side Effect Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

King's College London

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally healthy subjects.

Exclusion criteria

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

Treatment and study plan

Ferrous Sulfate

Dietary Supplement

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 names: ferrous sulphate

Placebo

Dietary Supplement

placebo capsules: methyl cellulose

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Medical Research Council

Other Gov

Collaborators

  • King's College London

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
May 23, 2014
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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