Vitamine d Dosage in Slow Transit Time ConstipationNCT03096704
Vitamine d Dosage and Constipation
An observational study of Vitamine d Dosage in Slow Transit Time Constipation, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
Vitamine d dosage in important to define nutritional status and bone metabolism. For patients with intestinal disorders it is important to establish the intestinal absorptive function. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Vitamine d Dosage in Slow Transit Time Constipation
- What is being tested?
- vitamine d dosage
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2017to 15 May 2017
- Phase
- Observational
- 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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: observational prospective study
Who may be able to join
- slow transit time constipation
Who cannot join
- drugs assumption comorbidity
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Alba Panarese
Noci, Apulia, 70015
alba panarese, 3471401487, albapanarese@libero.it
About this study
Official title: Vitamine D Deficiency in Slow Transit Time Constipation
Vitamine d dosage in important to define nutritional status and bone metabolism. For patients with intestinal disorders it is important to establish the intestinal absorptive function.
It is important to establish the absorption of vitamin D which correlate with different biological activity and bone metabolism, immune function and the communication between the cells.
Read the detailed description
Constipation is a disease that involves poor intestinal functioning. The reduced intestinal motility slows down intestinal function. Up to make lower the dosage of vitamin D. Vitamin D helps many cellular activities and enhances the action of tissue,Its Your dosage allows you to evaluate the efficacy of intestinal function and to better understand its severity.
- Being tested
- vitamine d dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamine d dosageDiagnostic test
dosage of vitamine D in slow transit time constipation
| Study group | Role | What they receive |
|---|---|---|
| slow transit time constipation | Not described Receives: Diagnostic Test: vitamine d dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
dosage of vitamine D
dosage of vitamine d in slow transit time constipation
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start30 Jan 2017
- Primary completion30 Apr 2017 (estimated)
- Study completion15 May 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamine d Dosage in Slow Transit Time ConstipationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alba panarese, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096704
- Sponsor's protocol ID
- 29
- Status last verified
- Mar 2017
- First submitted
- 26 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamine D Deficiency in Slow Transit Time Constipation
- ClinicalTrials.gov ID
- NCT03096704
- Acronym / sponsor ID
- 29
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 Apr 2017 (estimated)
- Study completion
- 15 May 2017 (estimated)
- First posted
- 30 Mar 2017 (actual)
- 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.
Vitamine d dosage in important to define nutritional status and bone metabolism. For patients with intestinal disorders it is important to establish the intestinal absorptive function.
It is important to establish the absorption of vitamin D which correlate with different biological activity and bone metabolism, immune function and the communication between the cells.
Detailed description
Constipation is a disease that involves poor intestinal functioning. The reduced intestinal motility slows down intestinal function. Up to make lower the dosage of vitamin D. Vitamin D helps many cellular activities and enhances the action of tissue,Its Your dosage allows you to evaluate the efficacy of intestinal function and to better understand its severity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| slow transit time constipation | – | Diagnostic Test: vitamine d dosage |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- observational prospective study
Key inclusion criteria (1 listed)
- slow transit time constipation
Key exclusion criteria (1 listed)
- drugs assumption comorbidity
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 |
|---|---|---|
| vitamine d dosagedosage of vitamine D in slow transit time constipation | Diagnostic test | slow transit time constipation |
Primary outcome
dosage of vitamine D
Time frame: 4 months
dosage of vitamine d in slow transit time constipation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamine d Dosage in Slow Transit Time Constipation, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 31 Mar 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alba panarese (3471401487, albapanarese@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dosage of vitamine D (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2017.