NCT02222649

Brief Summary

A vitamin D3 high dose would act as an antioxidant and anti-inflammatory improving markers of oxidative stress and inflammation in the elderly. Seniors exhibiting polymorphism in the VDR gene would become non-responsive to supplementation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

August 1, 2014

Enrollment Period

10 months

First QC Date

August 15, 2014

Last Update Submit

March 4, 2015

Conditions

Disorder of Aging

Keywords

Elderlyvitamin D insufficiencyHigh dose vitamin D3 supplementationPolymorphism of the VDR gene

Outcome Measures

Primary Outcomes (1)

  • number of elderly women with sufficient vitamin D levels

    four weeks after the intervention

Secondary Outcomes (4)

  • number of elderly who have reduced serum levels of High-Sensitivity C-Reactive Protein

    four weeks after the intervention

  • number of elderly who have reduced serum levels of Alpha 1 Acid Glycoprotein

    four weeks after the intervention

  • number of elderly who have reduced plasma levels of malondialdehyde (MDA)

    four weeks after the intervention

  • number of elderly that increased plasma antioxidant full capacity

    four weeks after the intervention

Other Outcomes (1)

  • Number of Participants with Polymorphism of the VDR gene

    Participants will be followed for the duration of recruitment , an expected average of 1 week

Study Arms (2)

Vitamin D3

EXPERIMENTAL

Group supplemented with high single dose of 200,000 IU of vitamin D3 (cholecalciferol)

Dietary Supplement: Vitamin D3

placebo group

PLACEBO COMPARATOR

Placebo capsules with starch

Dietary Supplement: Placebo

Interventions

Vitamin D3DIETARY_SUPPLEMENT

High dose of 200,000 IU of cholecalciferol orally in a single dose

Also known as: cholecalciferol, High dose
Vitamin D3
PlaceboDIETARY_SUPPLEMENT

Capsules of starch, no therapeutic action

placebo group

Eligibility Criteria

Age60 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • excluded from the study in the elderly using vitamin D supplements; anticonvulsant drugs or for the treatment of HIV / AIDS; diagnosis of type I diabetes mellitus, nephrotic syndrome, acute or chronic renal failure, liver disease, hypothyroidism, hyperthyroidism, history of cerebrovascular accident (CVA) or acute myocardial infarction (AMI) Vascular past 6 months and chronic consumptive diseases, alcoholic or smoker chronic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Program for Attention to Elderly, belonging to the Municipality of João Pessoa

João Pessoa, Paraíba, Brazil

RECRUITING

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Isa Gabriela M Cavalcante, DDS

    Federal University of Paraíba

    PRINCIPAL INVESTIGATOR

  • Maria da Conceição R Gonçalves, PDH

    Federal University of Paraíba

    STUDY DIRECTOR

  • Alexandre S Silva, PHD

    Federal University of Paraíba

    STUDY DIRECTOR

Central Study Contacts

Isa Gabriela M Cavalcante, DDS

CONTACT

+55 (83) 9112 0584isa.gabriela@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student

Study Record Dates

First Submitted

August 15, 2014

First Posted

August 21, 2014

Study Start

July 1, 2014

Primary Completion

May 1, 2015

Study Completion

September 1, 2015

Last Updated

March 6, 2015

Record last verified: 2014-08

Locations

BR(1)