Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.
NCT ID: NCT02146053
Last Updated: 2017-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
20 participants
INTERVENTIONAL
2004-03-31
2004-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GI Effects of Iron in Healthy Volunteers
NCT04705662
Iron Supplementation and Side Effects
NCT04018300
Analysis of the Effect of Iron Supplements on Iron Deficiency Anemia in Pregnancy
NCT05804071
Oral Lactoferrin Versus Iron Supplementation During Pregnancy
NCT03542825
Do Iron Supplements Impact the Gut Microbiome of Women of Reproductive Age?
NCT05033483
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ferrous sulfate
ferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period.
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.
Placebo
placebo taken at mealtimes twice daily during 1 week of the treatment period.
Placebo
placebo capsules: methyl cellulose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Placebo
placebo capsules: methyl cellulose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
King's College London
OTHER
Medical Research Council
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
dora pereira
Dr
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Miranda Lomer, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Jonathan Powell, PhD
Role: STUDY_CHAIR
MRC Human Nutrition Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
King's College London
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pereira DI, Couto Irving SS, Lomer MC, Powell JJ. A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation. BMC Gastroenterol. 2014 Jun 4;14:103. doi: 10.1186/1471-230X-14-103.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Symptoms KCL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.