Systemic Vitamin D Supplementation in Dental Implants Patients (VitaminD)

October 21, 2015 updated by: MARCO BOTELHO, University Potiguar

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04023-062
        • Marco Botelho
    • CE
      • Fortaleza, CE, Brazil, 60115-191
        • Gynelogical Center
    • RN
      • Natal, RN, Brazil, 59060
        • University Potiguar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vit D
Vit D 20 mg/day
Drug: Vit D
20 mg/day
Other Names:
  • Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
25 OH Serum levels
Time Frame: 2 years
VIT D Serum levels
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteoporosis condition
Time Frame: 2 years
Densitometry in patients femur bones
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Potiguar

Investigators

  • Study Chair: Gugliemo G Campus, PhD, Università degli Studi di Sassari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Estimate)

October 22, 2015

Last Update Submitted That Met QC Criteria

October 21, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVIDENCE x UNP VITAMIN D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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