Osteoporosis, Sarcopenia
Conditions
Keywords
Sarcopenia intervention study, sarcopenia
Brief summary
This will be three-arm parallel group trial. The goal of this intervention study is to observe the effect of vitamin D3 and calcium supplementation for the period of 6 months on improving the sarcopenia indices such as appendicular muscle mass, muscle strength and muscle function as well as bone density among rural post-menopausal women between age 40 to 65 years. The main questions it aims to answer are: 1. Does the Vitamin D3 supplementation alone help in improving sarcopenia measures or the addition of Calcium supplement along with Vitamin D3 will be more effective in improvement of muscle mass, muscle strength and muscle function. 2. Does Vitamin D3 and Calcium supplementation improve the bone density on supplementation for the period of 6 months among post-menopausal women. Participants will be given supplementation in three groups in which first group will receive vitamin D3 and calcium supplementation, second group will receive only vitamin D3 supplementation and third group will receive placebo in the form of vitamin B-Complex tablet. Calcium tablet of 500 mg was given daily for the period of 1 month and compliance was checked by collecting empty blisters of tablets from the participants. Vitamin D3 (60,000IU) tablet was given once a month and compliance were checked by observing direct consumption of tablet in front of the care provider/trained social worker. Participants will be measured at the baseline for their muscle and bone parameters and they will visit after 6 months on completion of their supplementation. Researcher will compare both the supplementation arms (Calcium and vitamin D3 with vitamin D3 alone) with each other and with the third arm of placebo group (supplemented with vitamin B-complex tablet).
Interventions
DIETARY_SUPPLEMENTTablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month.
Oral Calcium Carbonate supplement 500 mg from La Renon Healthcare Pvt Ltd to be administered daily for the period of 6 months. Oral Vitamin D3 (Cholecalciferol) supplement 60,000 IU from Eris Lifesciences Ltd to be administered once a month for the period of 6 months.
DIETARY_SUPPLEMENTTablet Tayo- Vitamin D3 (Cholecalciferol) (60,000 IU) once a month.
Oral Vitamin D3 (Cholecalciferol) supplement 60,000 IU from Eris Lifesciences Ltd to be administered once a month for the period of 6 months.
OTHERControl Group
No additional intervention was given to control group.
Sponsors
Dr. Anuradha Khadilkar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy post-menopausal women 2. Age between 40-65 years.
Exclusion criteria
1. Women with co-morbidities such as diabetes, thyroid conditions, heart disease, chronic liver/kidney disease, present acute illness 2. Presence of any metal implants in bones 3. Women who have undergone hysterectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sarcopenia Indices | 6 months | Change in appendicular skeletal muscle index, muscle strength and muscle function in post-menopausal women after supplementation with calcium and vitamin D3 using DXA, JAMAR hand dynamometer and Short Physical Performance Battery |
| Bone density measures | 6 months | Change in bone mineral density at lumbar spine and femur neck in post-menopausal women after supplementation with calcium and vitamin D3 using DXA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D levels | 6 months. | Change in Serum vitamin D levels(ng/ml) will be assessed |
| Parathyroid Hormone (PTH) levels | 6 months | Change in PTH levels ( pg/ml ) will be assessed |
| Lipid Profile | 6 months | Change in total cholesterol, triglycerides, HDL, LDL and VLDL levels (mg/dl) will be assessed |
Countries
India
Outcome results
None listed