An Early Phase 1 interventional study of ferrous sulfate and Placebo in Anemia, Constipation and Diarrhea, sponsored by Medical Research Council. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-06.
Sponsored by Medical Research Council · Early Phase 1, Interventional, and Basic science
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).
1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.
This study's enrollment of 20 is below the median of 96 across 1,318 interventional studies indexed under Anemia.
Browse Anemia studies →Medical Research Council is the lead sponsor of 68 studies on the registry; none are open to participants now.
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Exclusion Criteria:
ferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period.
Dietary Supplement: ferrous sulfate
placebo taken at mealtimes twice daily during 1 week of the treatment period.
Dietary Supplement: Placebo
ferrous sulphate (200 mg capsules containing 65 mg of iron) to be taken at mealtimes twice daily for 7 days during the treatment period.
Also known as: ferrous sulphate
placebo capsules: methyl cellulose
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).
Time frame: 14 days
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ferrous sulfate
Medical Research Council