NCT02582892

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2012

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

October 20, 2015

Last Update Submit

October 21, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 25 OH Serum levels

    VIT D Serum levels

    2 years

Secondary Outcomes (1)

  • Osteoporosis condition

    2 years

Study Arms (1)

Vit D

OTHER

Vit D 20 mg/day

Drug: Vit D

Interventions

Vit DDRUG

20 mg/day

Also known as: Vitamin D
Vit D

Eligibility Criteria

Age3 Months - 5 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- Menopause patients

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gynelogical Center

Fortaleza, Ceará, 60115-191, Brazil

Location

University Potiguar

Natal, Rio Grande do Norte, 59060, Brazil

Location

Marco Botelho

São Paulo, São Paulo, 04023-062, Brazil

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Osteoporosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Gugliemo G Campus, PhD

    Università degli Studi di Sassari

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director of Graduate Biotechnology

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 21, 2015

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2015

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations