Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.

Study Overview
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Brief Summary
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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).

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

Conditions
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Anemia, Constipation, Diarrhea, Abdominal Pain, Heartburn, Side Effect

Intervention / Treatment
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* Dietary Supplement: ferrous sulfate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy subjects. Exclusion Criteria: The presence of any chronic disease, pregnancy or lactation were considered as exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ferrous sulfate<br>ferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period. | Dietary Supplement: ferrous sulfate<br>* ferrous sulphate (200 mg capsules containing 65 mg of iron) to be taken at mealtimes twice daily for 7 days during the treatment period.<br>* Other names: ferrous sulphate;|
| Placebo Comparator: Placebo<br>placebo taken at mealtimes twice daily during 1 week of the treatment period. | Dietary Supplement: Placebo<br>* placebo capsules: methyl cellulose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy participants, gastrointestinal side-effects associated with oral iron