Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02146053

Enrollment

Registered

2014-05-23

Start date

2004-03-31

Completion date

2004-12-31

Last updated

2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

healthy participants, gastrointestinal side-effects associated with oral iron

Brief 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).

Interventions

DIETARY_SUPPLEMENTferrous 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.

DIETARY_SUPPLEMENTPlacebo

placebo capsules: methyl cellulose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Generally healthy subjects.

Exclusion criteria

* The presence of any chronic disease, pregnancy or lactation were considered as

Design outcomes

Primary

Measure	Time frame	Description
gastrointestinal symptoms	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).

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026