OsteoporosisPhase 4VitaminDNCT02582892
Systemic Vitamin D Supplementation in Dental Implants Patients
A Phase 4 study testing Vit D in people with Osteoporosis, run by University Potiguar at 3 sites in Brazil.
Trial summary
Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation and remodeling. Read more about this study
- Who is it for?
- Ages 3 months to 5 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Vit D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 3 sitesBrazil
- Study dates
- Oct 2012to Oct 2015
- 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 3 months to 5 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Menopause patients
Who cannot join
- patients with a past history of neurological disorder;
- who had received pharmacotherapy for depression within 8 weeks of screening;
- who were taking medication known to interfere with Vit D;
- who had recent psychiatricor systemic illness;
- uncontrolled hypertension (blood pressure > 160/95mmHg);
- unstable cardiovascular disease;
- User of psychoactive medications;
- alcohol excess consumption abuse.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Gynelogical Center
Fortaleza, Ceará, 60115-191
University Potiguar
Natal, Rio Grande do Norte, 59060
Marco Botelho
São Paulo, São Paulo, 04023-062
About this study
Official title: Systemic Vitamin D Supplementation in Menopausal Women With Dental Implants
Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation and remodeling.
Read the detailed description
Evidence has demonstrated that vitamin D deficiency plays an important role in dental implants outcomes.
Low serum levels of Vitamin D is considered as a risk factor, not only for low mineral bone density but also in other metabolic pathways such as those involved in immune response and chronic inflammatory diseases.
There are few studies demonstrating the role that vitamin D deficiency in the etiopathogenesis of oral diseases and the consequences in Dental Implants.
Dentists have not yet well understood the importance of a good bone metabolism response for a successful bone regeneration and osseointegration of implants.
An insufficient bone response can not guarantee the necessary stability of the implants placed in it, has been one of the biggest problems of implantology.
Thus, the aim of this study is to evaluate the efficacy of Systemic vitamin D supplementation in menopausal women cadidates for dental implants.
- Conditions
- Osteoporosis
- Being tested
- Vit D
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit DDrug
Also called Vitamin D
20 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Vit D | Other | Vit D 20 mg/day Receives: Drug: Vit D |
What is being measured
The primary outcome is the main question the study is designed to answer.
25 OH Serum levels
VIT D Serum levels
Measured: 2 years
Secondary outcomes (1)
Osteoporosis condition
Densitometry in patients femur bones
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Potiguar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCO BOTELHO, University Potiguar
- Investigators
- Gugliemo G Campus, PhD, Study chair, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582892
- Sponsor's protocol ID
- EVIDENCE x UNP VITAMIN D
- Acronym
- VitaminD
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.
PubMed 24519196Botelho MA, Martins JG, Ruela RS, Queiroz DB, Ruela WS. Nanotechnology in ligature-induced periodontitis: protective effect of a doxycycline gel with nanoparticules. J Appl Oral Sci. 2010 Jul-Aug;18(4):335-42. doi: 10.1590/s1678-77572010000400003.
PubMed 20835566
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Vitamin D Supplementation in Menopausal Women With Dental Implants
- ClinicalTrials.gov ID
- NCT02582892
- Acronym / sponsor ID
- VitaminD / EVIDENCE x UNP VITAMIN D
- Conditions
- Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University PotiguarUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Oct 2015 (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.
Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation and remodeling.
Detailed description
Evidence has demonstrated that vitamin D deficiency plays an important role in dental implants outcomes.
Low serum levels of Vitamin D is considered as a risk factor, not only for low mineral bone density but also in other metabolic pathways such as those involved in immune response and chronic inflammatory diseases.
There are few studies demonstrating the role that vitamin D deficiency in the etiopathogenesis of oral diseases and the consequences in Dental Implants.
Dentists have not yet well understood the importance of a good bone metabolism response for a successful bone regeneration and osseointegration of implants.
An insufficient bone response can not guarantee the necessary stability of the implants placed in it, has been one of the biggest problems of implantology.
Thus, the aim of this study is to evaluate the efficacy of Systemic vitamin D supplementation in menopausal women cadidates for dental implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vit D | Other | Drug: Vit DVit D 20 mg/day |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Menopause patients
Key exclusion criteria (8 listed)
- patients with a past history of neurological disorder;
- who had received pharmacotherapy for depression within 8 weeks of screening;
- who were taking medication known to interfere with Vit D;
- who had recent psychiatricor systemic illness;
- uncontrolled hypertension (blood pressure > 160/95mmHg);
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 |
|---|---|---|
| Vit DAlso: Vitamin D20 mg/day | Drug | Vit D |
Primary outcome
25 OH Serum levels
Time frame: 2 years
VIT D Serum levels
1 secondary outcome
Osteoporosis condition
Time frame: 2 years
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 22 Oct 2015.
- Results publication: PubMed 24519196Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.
- Results publication: PubMed 20835566Botelho MA, Martins JG, Ruela RS, Queiroz DB, Ruela WS. Nanotechnology in ligature-induced periodontitis: protective effect of a doxycycline gel with nanoparticules. J Appl Oral Sci. 2010 Jul-Aug;18(4):335-42. doi: 10.1590/s1678-77572010000400003.
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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.
Gugliemo G Campus, PhD study chair
Università degli Studi di Sassari
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vit D in people with Osteoporosis, run by University Potiguar at 3 sites in Brazil.
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 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 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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?
25 OH Serum levels (time frame: 2 years). 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 NCT02582892, which also lists 2 linked publications.
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 22 Oct 2015.