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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02146053
Other study ID # Symptoms KCL
Secondary ID
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
Health authority
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.

Study Design


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
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