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Effects of Vitamin D Supplementation in Muscle Strength and Balance Training

NCT03367585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-04-24

No results posted yet for this study

Summary

Introduction: In Brazil, a person who is sixty years old or more is considered elderly. The incidence of osteoporosis and osteopenia has been increasing, as have fractures resulting from falls. Vitamin D deficiency can cause muscular atrophy in type II fibers (fast contraction and strength), which can increase the risk of falls. The aging process produces reduction in the ability of postural control system to maintain postural balance, which may increase postural instability and consequently increase the elderly risk to falls. Objective: To evaluate if vitamin D supplementation associated with regular exercise in vulnerable older women improves muscle strength and postural balance in 12 weeks. Methods: This will be a randomized prospective clinical trial, double blind, placebo-controlled intervention. Will be part of the study 40 elderly women vulnerable, who meet the inclusion criteria and that will be coming from the community through calls made by radio and social network. The volunteer will undergoing to blood test, body composition and bone mineral density, Mini Mental State Examination, Geriatric Depressive Scale, Falls Efficacy Scale, WHOQOL-OLD and WHOQOL-BREF instruments, functional capacity tests (MiniBEST, Time up and Go, Chair Rising Test, Six-minute walk test), muscular strength assessment (isokinetic dynamometry, handgrip and 1RM test) and postural balance (AccSway force platform for static postural balance and NeuroCom's Balance Master for dynamic postural balance) before and after 12 weeks of intervention with vitamin D supplementation and resistance and postural balance exercise. The intervention that will be perform during the 12 weeks with a progressive resistance training program.

Conditions

  • Osteoporosis, Osteopenia
  • Osteoporosis, Postmenopausal

Interventions

DIETARY_SUPPLEMENT

Physical exercise + Vitamin D3

Strength exercise + Supplementation of vitamin D3 50,000 IU / week

OTHER

Physical exercise

Strength exercise

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2018-12-01
Completion
2020-04-22

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03367585 on ClinicalTrials.gov