AnemiaEarly Phase 1NCT02146053
Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.
A Early Phase 1 study testing ferrous sulfate in people with Anemia and Constipation, run by Medical Research Council at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Constipation, Diarrhea
- What is being tested?
- ferrous sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2004to Dec 2004
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy subjects.
Who cannot join
- The presence of any chronic disease, pregnancy or lactation were considered as exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Simple Questionnaire to Assess Gastrointestinal Symptoms After Oral Ferrous Sulphate Supplementation.
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).
- Conditions
- Anemia, Constipation, Diarrhea, Abdominal Pain, Heartburn, Side Effect
- Being tested
- ferrous sulfate, Placebo
- Keywords
- healthy participants, gastrointestinal side-effects associated with oral iron
- Medical subject headings
- Anemia, Constipation, Diarrhea, Abdominal Pain, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferrous sulfateDietary supplement
Also called ferrous sulphate
ferrous sulphate (200 mg capsules containing 65 mg of iron) to be taken at mealtimes twice daily for 7 days during the treatment period.
PlaceboDietary supplement
placebo capsules: methyl cellulose
| Study group | Role | What they receive |
|---|---|---|
| Ferrous sulfate | Active comparator | ferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period. Receives: Dietary Supplement: ferrous sulfate |
| Placebo | Placebo comparator | placebo taken at mealtimes twice daily during 1 week of the treatment period. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startMar 2004
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Collaborators
- King's College London
- Responsible party
- Principal investigator, dora pereira, Medical Research Council
- Investigators
- Miranda Lomer, PhD, Principal investigator, King's College LondonJonathan Powell, PhD, Study chair, MRC Human Nutrition Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146053
- Sponsor's protocol ID
- Symptoms KCL
- Status last verified
- Feb 2017
- First submitted
- 21 May 2014
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24899360
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Simple Questionnaire to Assess Gastrointestinal Symptoms After Oral Ferrous Sulphate Supplementation.
- ClinicalTrials.gov ID
- NCT02146053
- Acronym / sponsor ID
- Symptoms KCL
- Conditions
- Anemia, Constipation, Diarrhea, Abdominal Pain, Heartburn, Side Effect
- Keywords
- healthy participants, gastrointestinal side-effects associated with oral iron
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical Research CouncilOther government
- Collaborators
- King's College London
- Study start
- Mar 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous sulfate | Active comparator | Dietary Supplement: ferrous sulfateferrous sulfate taken at mealtimes twice daily during 1 week of the treatment period. |
| Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo taken at mealtimes twice daily during 1 week of the treatment period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generally healthy subjects.
Key exclusion criteria (1 listed)
- The presence of any chronic disease, pregnancy or lactation were considered as exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ferrous sulfateAlso: ferrous sulphateferrous sulphate (200 mg capsules containing 65 mg of iron) to be taken at mealtimes twice daily for 7 days during the treatment period. | Dietary supplement | Ferrous sulfate |
| Placeboplacebo capsules: methyl cellulose | Dietary supplement | Placebo |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Derived from this study: PubMed 24899360Pereira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miranda Lomer, PhD principal investigator
King's College London
Jonathan Powell, PhD study chair
MRC Human Nutrition Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ferrous sulfate in people with Anemia and Constipation, run by Medical Research Council at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastrointestinal symptoms (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02146053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.