ClinicalTrials.Veeva

Menu

Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis

U

University of Alexandria

Status

Completed

Conditions

Sarcopenia

Treatments

Drug: Vitamin D
Other: Physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT01666522
alexmed116671002

Details and patient eligibility

About

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.

Full 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.

Enrollment

145 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

145 participants in 4 patient groups, including a placebo group

Vitamin D
Experimental group
Description:
vitamin D-oral cholecalciferol 2000 IU/day for 4 months
Treatment:
Drug: Vitamin D
Physical activity
Active Comparator group
Description:
A 3-day/week exercise programme lasting 60 minutes each day for 4 months was instigated.
Treatment:
Other: Physical activity
Vitamin D and Physical activity
Experimental group
Description:
Vitamin D -oral cholecalciferol 2000 IU/day and Physical activity-60-minute 3-day/week exercise programme
Treatment:
Other: Physical activity
Drug: Vitamin D
Control
Placebo Comparator group
Description:
The control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health.
Treatment:
Drug: Vitamin D

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems