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Systemic Vitamin D Supplementation in Dental Implants Patients (VitaminD)

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Vit D

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

3 Months - 5 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

- Menopause patients

Exclusion Criteria:

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.

Sites / Locations

Gynelogical Center
University Potiguar
Marco Botelho

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Vit D

Arm Description

Vit D 20 mg/day

Outcomes

Primary Outcome Measures

25 OH Serum levels

VIT D Serum levels

Secondary Outcome Measures

Osteoporosis condition

Densitometry in patients femur bones

Full Information

NCT ID

NCT02582892

First Posted

October 20, 2015

Last Updated

October 21, 2015

Sponsor

University Potiguar

1. Study Identification

Unique Protocol Identification Number

NCT02582892

Brief Title

Systemic Vitamin D Supplementation in Dental Implants Patients

Acronym

VitaminD

Official Title

Systemic Vitamin D Supplementation in Menopausal Women With Dental Implants

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Potiguar

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

135 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vit D

Arm Type

Other

Arm Description

Vit D 20 mg/day

Intervention Type

Drug

Intervention Name(s)

Vit D

Other Intervention Name(s)

Vitamin D

Intervention Description

20 mg/day

Primary Outcome Measure Information:

Title

25 OH Serum levels

Description

VIT D Serum levels

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Osteoporosis condition

Description

Densitometry in patients femur bones

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Menopause patients Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gugliemo G Campus, PhD

Organizational Affiliation

Università degli Studi di Sassari

Official's Role

Study Chair

Facility Information:

Facility Name

Gynelogical Center

City

Fortaleza

State/Province

ZIP/Postal Code

60115-191

Country

Brazil

Facility Name

University Potiguar

City

Natal

State/Province

ZIP/Postal Code

59060

Country

Brazil

Facility Name

Marco Botelho

City

Sao Paulo

ZIP/Postal Code

04023-062

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

24519196

Citation

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.

Results Reference

result

PubMed Identifier

20835566

Citation

Botelho 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.

Results Reference

result

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Systemic Vitamin D Supplementation in Dental Implants Patients

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