Effect of Oral Vitamin D3 and Calcium Supplementation on Muscle and Bone Health Among Rural Post-menopausal Women
NCT ID: NCT06900387
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2021-06-08
2022-09-23
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A- Calcium and Vitamin D3
Calcium Carbonate tablet (500 mg)- daily for the period of 6 months. Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month for the period of 6 months.
Tablet 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.
Group B- Vitamin D3
Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month for the period of 6 months.
Tablet 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.
Group C- Control Group
This was a control group. No additional intervention was given to control group.
Control Group
No additional intervention was given to control group.
Interventions
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Tablet 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.
Tablet 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.
Control Group
No additional intervention was given to control group.
Eligibility Criteria
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Inclusion Criteria
2. Age between 40-65 years.
Exclusion Criteria
2. Presence of any metal implants in bones
3. Women who have undergone hysterectomy.
40 Years
65 Years
FEMALE
Yes
Sponsors
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Dr. Anuradha Khadilkar
OTHER
Responsible Party
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Dr. Anuradha Khadilkar
Deputy Director
Locations
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Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune
Pune, Maharashtra, India
Countries
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Other Identifiers
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JCDC/BHR/23/044
Identifier Type: -
Identifier Source: org_study_id
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