ClinicalTrials.gov
ClinicalTrials.gov Menu

Systemic Vitamin D Supplementation in Dental Implants Patients (VitaminD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02582892
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
MARCO BOTELHO, University Potiguar

Brief Summary:
Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation and remodeling.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Vit D Phase 4

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  (Clinical Trial)
Actual Enrollment : 135 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systemic Vitamin D Supplementation in Menopausal Women With Dental Implants
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Vit D
Vit D 20 mg/day
Drug: Vit D
20 mg/day
Other Name: Vitamin D




Primary Outcome Measures :
  1. 25 OH Serum levels [ Time Frame: 2 years ]
    VIT D Serum levels


Secondary Outcome Measures :
  1. Osteoporosis condition [ Time Frame: 2 years ]
    Densitometry in patients femur bones



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582892


Locations
Brazil
Gynelogical Center
Fortaleza, CE, Brazil, 60115-191
University Potiguar
Natal, RN, Brazil, 59060
Marco Botelho
Sao Paulo, Brazil, 04023-062
Sponsors and Collaborators
University Potiguar
Investigators
Study Chair: Gugliemo G Campus, PhD Università degli Studi di Sassari

Publications of Results:
Responsible Party: MARCO BOTELHO, Program Director of Graduate Biotechnology, University Potiguar
ClinicalTrials.gov Identifier: NCT02582892     History of Changes
Other Study ID Numbers: EVIDENCE x UNP VITAMIN D
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Vitamins
Vitamin D
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents