Vitamin D DeficiencyPhase 4NCT02158598
Comparison of Changes in Serum 25(OH)D Concentrations Following Vitamin D Supplementation With Chewable Tablets Versus Pills
A Phase 4 study testing Vitamin D chewable tablet supplementation and Vitamin D pill supplementation in people with Vitamin D Deficiency, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
This is a 6-month cross-over trial of vitamin D supplementation in 38 healthy men and women aged 18 years and older. The primary aim is to compare the change in serum 25(OH)D concentration following vitamin D supplementation with chewable tablets versus pills. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D chewable tablet supplementation and Vitamin D pill supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to 9 May 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian men and women;
- Aged 18 years and older;
- Having a serum 25(OH)D concentration of 75 nmol/L or less.
Who cannot join
- Regular consumption of a supplement containing > 400 IU/d of vitamin D over the last 2 months;
- Intestinal malabsorption;
- Cirrhosis;
- Renal insufficiency (creatinine clearance <60 ml/min);
- Hypercalcemia;
- Pregnancy;
- Breastfeeding;
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
CHU de Québec Research Centre, Laval University
Québec, Quebec, g1v 4g2
About this study
This is a 6-month cross-over trial of vitamin D supplementation in 38 healthy men and women aged 18 years and older. The primary aim is to compare the change in serum 25(OH)D concentration following vitamin D supplementation with chewable tablets versus pills. Secondary aims are to evaluate satisfaction and adherence to the vitamin D chewable tablet supplement. Questionnaires on physical activity, sunlight exposure and dairy product consumption will be administered to adjust for confounding factors. A questionnaire will be administered to assess satisfaction and pill count to evaluate adherence to treatment. This research intends to test the hypothesis that the vitamin D chewable tablet supplement is as effective as a traditional vitamin D pill supplement to increase serum 25(OH)D concentrations.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D chewable tablet supplementation, Vitamin D pill supplementation
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D chewable tablet supplementationDrug
Vitamin D pill supplementationDrug
| Study group | Role | What they receive |
|---|---|---|
| wash-out | No intervention | 2 months |
| Vitamin D chewable tablet supplementation | Experimental | A chewable vitamin D tablet containing 1000 IU to be taken once a day for 2 months. Receives: Drug: Vitamin D chewable tablet supplementation |
| Vitamin D pill supplementation | Experimental | A vitamin D pill containing 1000 IU to be taken once a day for 2 months. Receives: Drug: Vitamin D pill supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum 25(OH)D concentration
Measured: 0 and 2 months, 4 and 6 months
Secondary outcomes (2)
Satisfaction with the vitamin D chewable tablets and pills.
Satisfaction will be assessed using a questionnaire administered by the research team.
Measured: 0 and 2 months, 4 and 6 months
Adherence to the vitamin D chewable tablets and pills.
This issue will be assessed by pill count.
Measured: 0 and 2 months, 4 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Khlôros Technology, Anne-Sophie Morisset
- Responsible party
- Principal investigator, Claudia Gagnon, CHU de Quebec-Universite Laval
- Investigators
- Claudia Gagnon, MD, Principal investigator, CHU de Québec Research Centre and Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158598
- Sponsor's protocol ID
- B14-03-1896
- Status last verified
- Jul 2018
- First submitted
- 2 Jun 2014
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Changes in Serum 25(OH)D Concentrations Following Vitamin D Supplementation With Chewable Tablets Versus Pills
- ClinicalTrials.gov ID
- NCT02158598
- Acronym / sponsor ID
- B14-03-1896
- Conditions
- Vitamin D Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Khlôros Technology, Anne-Sophie Morisset
- Study start
- Jun 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 9 Jun 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.
This is a 6-month cross-over trial of vitamin D supplementation in 38 healthy men and women aged 18 years and older. The primary aim is to compare the change in serum 25(OH)D concentration following vitamin D supplementation with chewable tablets versus pills. Secondary aims are to evaluate satisfaction and adherence to the vitamin D chewable tablet supplement. Questionnaires on physical activity, sunlight exposure and dairy product consumption will be administered to adjust for confounding factors. A questionnaire will be administered to assess satisfaction and pill count to evaluate adherence to treatment. This research intends to test the hypothesis that the vitamin D chewable tablet supplement is as effective as a traditional vitamin D pill supplement to increase serum 25(OH)D concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| wash-out | No intervention | –2 months |
| Vitamin D chewable tablet supplementation | Experimental | Drug: Vitamin D chewable tablet supplementationA chewable vitamin D tablet containing 1000 IU to be taken once a day for 2 months. |
| Vitamin D pill supplementation | Experimental | Drug: Vitamin D pill supplementationA vitamin D pill containing 1000 IU to be taken once a day for 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Caucasian men and women;
- Aged 18 years and older;
- Having a serum 25(OH)D concentration of 75 nmol/L or less.
Key exclusion criteria (8 listed)
- Regular consumption of a supplement containing > 400 IU/d of vitamin D over the last 2 months;
- Intestinal malabsorption;
- Cirrhosis;
- Renal insufficiency (creatinine clearance <60 ml/min);
- Hypercalcemia;
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 |
|---|---|---|
| Vitamin D chewable tablet supplementation | Drug | Vitamin D chewable tablet supplementation |
| Vitamin D pill supplementation | Drug | Vitamin D pill supplementation |
Primary outcome
Change in Serum 25(OH)D concentration
Time frame: 0 and 2 months, 4 and 6 months
2 secondary outcomes
Satisfaction with the vitamin D chewable tablets and pills.
Time frame: 0 and 2 months, 4 and 6 months
Adherence to the vitamin D chewable tablets and pills.
Time frame: 0 and 2 months, 4 and 6 months
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 30 Jul 2018.
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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.
Claudia Gagnon, MD principal investigator
CHU de Québec Research Centre and Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D chewable tablet supplementation and Vitamin D pill supplementation in people with Vitamin D Deficiency, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 3 inclusion and 8 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 30 Jul 2018. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in Serum 25(OH)D concentration (time frame: 0 and 2 months, 4 and 6 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 30 Jul 2018.