Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000592842
Ethics application status
Approved
Date submitted
30/05/2012
Date registered
1/06/2012
Date last updated
19/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Neural adaptations to vitamin D supplementation in older adults: A pilot study
Scientific title
Effects of vitamin D supplementation on muscle function and neural activity in older women with insufficient serum 25-hydroxyvitamin D levels: A pilot study.
Secondary ID [1] 280415 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 286383 0
Falls 286384 0
Vitamin D deficiency 286599 0
Condition category
Condition code
Neurological 286629 286629 0 0
Studies of the normal brain and nervous system
Musculoskeletal 286630 286630 0 0
Other muscular and skeletal disorders
Diet and Nutrition 286874 286874 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 3-month double-blinded, placebo controlled trial. Women allocated to the vitamin D treatment group will be asked to take 2x1000 IU vitamin D3 supplements (oral tablet, Blackmores Vitamin D3) per day for 3 months.
Intervention code [1] 284967 0
Treatment: Drugs
Comparator / control treatment
Participants randomised to the placebo group will be asked to take two identical (matched) placebo supplement per day for 3 months.
Control group
Placebo

Outcomes
Primary outcome [1] 287211 0
Neural excitability and inhibition measured by Transcranial Magnetic Stimulation (TMS)
Timepoint [1] 287211 0
Meausrements will be made at baseline and 3 months
Primary outcome [2] 287212 0
Muscle function (number of chair-rises within 30 s; 3-metre timed-up-and-go test, the four-square test, where subjects must step around four squares in one direction and back again)
Timepoint [2] 287212 0
Meausrements will be made at baseline and 3 months
Secondary outcome [1] 297641 0
Maximal muscle force (strength) and power for the muscles of the legs (Biodex machine)
Timepoint [1] 297641 0
Meausrements will be made at baseline and 3 months
Secondary outcome [2] 297642 0
Serum 25-hydroxyvitamin D
Timepoint [2] 297642 0
Meausrements will be made at baseline and 3 months
Secondary outcome [3] 297643 0
Health-related quality of life assessed by the SF-36 questionnaire
Timepoint [3] 297643 0
Meausrements will be made at baseline and 3 months
Secondary outcome [4] 297644 0
Cognitive function (mini-mental state examination)
Timepoint [4] 297644 0
Meausrements will be made at baseline and 3 months

Eligibility
Key inclusion criteria
Healthy older women (aged 60 years and over) with insufficient serum vitamin D levels (25-hydroxyvitamin D between 25 and 60 nmol/L) who are able to speak English proficiently and walk unaided or with minimal assistance (walking stick) for at least 50 m.
Minimum age
60 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be ineligible based on the following: 1) current or prior participation in resistance exercise (greater or equal to once a week) and/or participating in greater than 150 min of physical activity per week in the past 3 months, 2) acute or terminal illness likely to compromise exercise testing, 3) unstable or ongoing cardiovascular/ respiratory disorders, 4) musculoskeletal or neurological diseases disrupting voluntary movement or that might limit testing, 5) upper or lower extremity fracture in the past 3 months, 6) visual impairment not corrected with glasses; 7) unable to follow instructions; and 8) currently taking vitamin D supplements (greater than 200 IU/d), and 9) not willing to take vitamin D supplements or placebo supplements for 3 months.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised 1:1 to the vitamin D or placebo. Participants will be allocated numbered containers based on a central randomisation by computer with the code held by an external person not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list will be computer generated using a random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2012
Actual
18/06/2012
Date of last participant enrolment
Anticipated
Actual
10/08/2012
Date of last data collection
Anticipated
Actual
19/11/2012
Sample size
Target
30
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285341 0
University
Name [1] 285341 0
Deakin University
Country [1] 285341 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Centre for Physical Activity and Nutrition Research
221 Burwood Highway
Burwood, Melbourne
Victoria 3125
Country
Australia
Secondary sponsor category [1] 284193 0
None
Name [1] 284193 0
Address [1] 284193 0
Country [1] 284193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287352 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 287352 0
Deakin University
Deakin Research Integrity
221 Burwood Hwy
Burwood
Victoria 3125
Ethics committee country [1] 287352 0
Australia
Date submitted for ethics approval [1] 287352 0
Approval date [1] 287352 0
18/05/2012
Ethics approval number [1] 287352 0
2012-051

Summary
Brief summary
Low vitamin D levels in the blood are a common problem in the elderly. One of the main functions of vitamin D is to help absorb calcium to keep bones strong, but low vitamin D levels have been associated with muscle weakness and an increased risk of falls. Low vitamin D levels have also been linked to a number of neurological conditions such as multiple sclerosis and Parkinson’s disease. Since the role of the nervous system is to send signals to the muscles to produce smooth and coordinated movements to maintain balance and prevent falling, it is possible that the increased risk of falling that has been associated with low vitamin D levels is related to its effects on the brain and nervous system. This study has been designed to investigate the effects of 3-months of vitamin D supplementation on muscle strength, muscle power and function as well as neural activity in the brain and nervous system in older women with mild vitamin D deficiency. Women aged 60 years and over will be randomised to receive either 2000 IU of vitamin D supplementation daily or a matched placebo control. Women will undergo muscle strength and function tests as well as non-invasive neural testing prior to study commencement and after 3 months' supplementation.
Trial website
Trial related presentations / publications
Pirotta S, Kidgell D, Daly RM. Effects of vitamin D supplementation on neuroplasticity in older adults: a double-blinded, placebo-controlled randomised trial. Osteoporosis Int 26:131-40, 2015
Public notes

Contacts
Principal investigator
Name 34118 0
Prof Robin Daly
Address 34118 0
Deakin University Centre for Physical Activity and Nutrition Research 221 Burwood Highway Burwood, Melbourne Victoria 3125
Country 34118 0
Australia
Phone 34118 0
+61392446040
Fax 34118 0
Email 34118 0
rmdaly@deakin.edu.au
Contact person for public queries
Name 17365 0
Robin Daly
Address 17365 0
Deakin University
Centre for Physical Activity and Nutrition Research
221 Burwood Highway
Burwood, Melbourne
Victoria 3125
Country 17365 0
Australia
Phone 17365 0
+61392446040
Fax 17365 0
+61392446017
Email 17365 0
rmdaly@deakin.edu.au
Contact person for scientific queries
Name 8293 0
Robin Daly
Address 8293 0
Deakin University
Centre for Physical Activity and Nutrition Research
221 Burwood Highway
Burwood, Melbourne
Victoria 3125
Country 8293 0
Australia
Phone 8293 0
+61392446040
Fax 8293 0
+61392446017
Email 8293 0
rmdaly@deakin.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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