Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.

United Kingdom Research and Innovation (UKRI)

Status and phase: Completed; Early Phase 1

Conditions: Heartburn; Anemia; Diarrhea; Side Effect; Constipation; Abdominal Pain

Treatments: Dietary Supplement: ferrous sulfate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02146053

Symptoms KCL

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally healthy subjects.

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Ferrous sulfate

Active Comparator group

Description:

ferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period.

Treatment:

Dietary Supplement: ferrous sulfate

Placebo

Placebo Comparator group

Description:

placebo taken at mealtimes twice daily during 1 week of the treatment period.

Treatment:

Dietary Supplement: Placebo