Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.
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|ClinicalTrials.gov Identifier: NCT02146053|
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : February 6, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Anemia Constipation Diarrhea Abdominal Pain Heartburn Side Effect||Dietary Supplement: ferrous sulfate Dietary Supplement: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Validation of a Simple Questionnaire to Assess Gastrointestinal Symptoms After Oral Ferrous Sulphate Supplementation.|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2004|
Active Comparator: Ferrous sulfate
ferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period.
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.
Other Name: ferrous sulphate
Placebo Comparator: Placebo
placebo taken at mealtimes twice daily during 1 week of the treatment period.
Dietary Supplement: Placebo
placebo capsules: methyl cellulose
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146053
|King's College London|
|London, United Kingdom|
|Principal Investigator:||Miranda Lomer, PhD||King's College London|
|Study Chair:||Jonathan Powell, PhD||MRC Human Nutrition Research|