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Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis

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ClinicalTrials.gov Identifier: NCT01666522
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : August 16, 2012
Sponsor:
Information provided by (Responsible Party):
Anna Abou-Raya, University of Alexandria

Tracking Information
First Submitted Date  ICMJE August 3, 2012
First Posted Date  ICMJE August 16, 2012
Last Update Posted Date August 16, 2012
Study Start Date  ICMJE April 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2012)
  • muscle mass change [ Time Frame: 4 months ]
  • Muscle mass change [ Time Frame: 4 months ]
    To determine change in vitamin D status, fasting blood samples were collected from all participants at baseline and after 16 weeks of intervention and were measured by Liaison immunoassay. Muscle mass change and sarcopenia prevention was measured using the relative skeletal muscle index (appendicular skeletal muscle mass divided by height) below 5.45 kg/m2).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis
Official Title  ICMJE Effect of Vitamin D Supplementation and Physical Activity in Preventing Sarcopenia in Older Adults With Osteoporosis
Brief Summary

In the present study the aim was to determine the prevalence of sarcopenia and to evaluate the effectiveness of an exercise program and vitamin D supplementation in enhancing muscle mass and strength in community-dwelling older adults with osteopenia /osteoporosis.

One hundred and forty-five individuals aged 65 years and above with documented osteopenia/osteoporosis were scanned for sarcopenia. The participants were randomly assigned to one of four groups: Group 1-PA and vitamin D (n= 38), Group 2-PA(n=36), Group 3-vitamin D (n= 36) or Group 4-healthy lifestyle(n =35) for 16 weeks. The PA group received a 60-minute 3-day/week exercise programme, the vitamin D group received oral cholecalciferol 2000 IU/day and the control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health. Body composition was measured DEXA. Vitamin D levels were measured and PA was measured using the Baecke Physical Activity Questionnaire. Physical performance was assessed using upper limb grip strength, walking speed and knee extension strength. All data was collected at baseline and at 4 months.

Detailed Description

Ageing is associated with changes in body composition and due to the ageing of the populations and the lessened physical activity (PA), sarcopenia and osteopenia /osteoporosis are emerging as major health concerns. Lack of PA is a significant risk factor for sarcopenia. Vitamin D plays an important role on bone and muscle development.

This study was conducted to determine the prevalence of sarcopenia and to evaluate the effectiveness of PA and vitamin D supplementation in enhancing muscle mass and strength in community-dwelling older adults with osteopenia /osteoporosis.\ One hundred and forty-five individuals aged 65 years and above with documented osteopenia/osteoporosis were scanned for sarcopenia (defined as a relative skeletal muscle index (appendicular skeletal muscle mass divided by height) below 5.45 kg/m2). The participants were randomly assigned to one of four groups: Group 1-PA and vitamin D (n= 38), Group 2-PA(n=36), Group 3-vitamin D (n= 36) or Group 4-healthy lifestyle(n =35) for 16 weeks. The PA group received a 60-minute 3-day/week exercise programme, the vitamin D group received oral cholecalciferol 2000 IU/day and the control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health. Body composition was measured by dual energy X-ray absorptiometry (DEXA). Vitamin D levels were measured by Liaison immunoassay. PA was measured using the Baecke Physical Activity Questionnaire. Physical performance was assessed using upper limb grip strength, walking speed and knee extension strength. All data was collected at baseline and at 4 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Sarcopenia
Intervention  ICMJE
  • Drug: Vitamin D
    vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
    Other Name: cholecalciferol
  • Other: Physical activity
    Physical activity in the form of an exercise programme consisting of 60 minutes all inclusive warming up , strengthening, resistance and stretching exercises were instigated 3 times a week for 4 months.
    Other Name: Exercise programme
Study Arms  ICMJE
  • Experimental: Vitamin D
    vitamin D-oral cholecalciferol 2000 IU/day for 4 months
    Intervention: Drug: Vitamin D
  • Active Comparator: Physical activity
    A 3-day/week exercise programme lasting 60 minutes each day for 4 months was instigated.
    Intervention: Other: Physical activity
  • Experimental: Vitamin D and Physical activity
    Vitamin D -oral cholecalciferol 2000 IU/day and Physical activity-60-minute 3-day/week exercise programme
    Interventions:
    • Drug: Vitamin D
    • Other: Physical activity
  • Placebo Comparator: Control
    The control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health.
    Intervention: Drug: Vitamin D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2012)
145
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • older adults aged 60 and above
  • osteopenia/osteoporosis

Exclusion Criteria:

  • severe cognitive impairment
  • major organ disease
  • current consumption of corticosteroids or vitamin D
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01666522
Other Study ID Numbers  ICMJE alexmed116671002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anna Abou-Raya, University of Alexandria
Study Sponsor  ICMJE University of Alexandria
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alexandria
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP