Completed

Effect of Vitamin D Supplementation and Physical Activity in Preventing Sarcopenia in Older Adults With Osteoporosis

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What is being tested

Vitamin D

+ Physical activity

+ Vitamin D

DrugOther
Who is being recruted

Atrophy+13

+ Behavior

+ Bone Diseases

Over 60 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: April 2011
See protocol details

Summary

Principal SponsorUniversity of Alexandria
Last updated: August 16, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2011

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Alexandria
Last updated: August 16, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

145 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AtrophyBehaviorBone DiseasesMetabolic DiseasesMuscular AtrophyMusculoskeletal DiseasesNervous System DiseasesNeurologic ManifestationsNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalNeuromuscular ManifestationsBone Diseases, MetabolicMotor ActivitySarcopenia

Criteria

2 inclusion criteria required to participate
older adults aged 60 and above

osteopenia/osteoporosis

3 exclusion criteria prevent from participating
current consumption of corticosteroids or vitamin D

major organ disease

severe cognitive impairment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
vitamin D-oral cholecalciferol 2000 IU/day for 4 months

Group II

Active Comparator
A 3-day/week exercise programme lasting 60 minutes each day for 4 months was instigated.

Group III

Experimental
Vitamin D -oral cholecalciferol 2000 IU/day and Physical activity-60-minute 3-day/week exercise programme

Group IV

Placebo
The control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Faculty of Medicine

Alexandria, EgyptOpen Faculty of Medicine in Google Maps
CompletedOne Study Center