SarcopeniaNCT06900387
Effect of Oral Vitamin D3 and Calcium Supplementation on Muscle and Bone Health Among Rural Post-menopausal Women
A study testing Tablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month. and Tablet Tayo- Vitamin D3 (Cholecalciferol) (60,000 IU) once a month. in people with Sarcopenia and Osteoporosis, run by Dr. Anuradha Khadilkar at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Osteoporosis
- What is being tested?
- Tablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month. and Tablet Tayo- Vitamin D3 (Cholecalciferol) (60,000 IU) once a month.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteIndia
- Study dates
- 8 Jun 2021to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy post-menopausal women
- Age between 40-65 years.
Who cannot join
- Women with co-morbidities such as diabetes, thyroid conditions, heart disease, chronic liver/kidney disease, present acute illness
- Presence of any metal implants in bones
- Women who have undergone hysterectomy.
Trial locations and contacts
1 site in 1 country.
India1 site
Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune
Pune, Maharashtra, 411001
About this study
Official title: Effect of Oral Vitamin D3 and Calcium Supplementation on Sarcopenia Indices and Osteoporosis Among Rural Post-menopausal Women
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:
- 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.
- Does Vitamin D3 and Calcium supplementation improve the bone density on supplementation for the period of 6 months among post-menopausal women.
Read more
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).
- Conditions
- Sarcopenia, Osteoporosis
- Being tested
- Tablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month., Tablet Tayo- Vitamin D3 (Cholecalciferol) (60,000 IU) once a month., Control Group
- Keywords
- Sarcopenia intervention study, sarcopenia
- Medical subject headings
- Sarcopenia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month.Dietary supplement
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.Dietary supplement
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 GroupOther
No additional intervention was given to control group.
| Study group | Role | What they receive |
|---|---|---|
| Group A- Calcium and Vitamin D3 | Active comparator | 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. Receives: Dietary Supplement: Tablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month. |
| Group B- Vitamin D3 | Active comparator | Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month for the period of 6 months. Receives: Dietary Supplement: Tablet Tayo- Vitamin D3 (Cholecalciferol) (60,000 IU) once a month. |
| Group C- Control Group | Active comparator | This was a control group. No additional intervention was given to control group. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenia Indices
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
Measured: 6 months
Bone density measures
Change in bone mineral density at lumbar spine and femur neck in post-menopausal women after supplementation with calcium and vitamin D3 using DXA
Measured: 6 months
Secondary outcomes (3)
Vitamin D levels
Change in Serum vitamin D levels(ng/ml) will be assessed
Measured: 6 months.
Parathyroid Hormone (PTH) levels
Change in PTH levels ( pg/ml ) will be assessed
Measured: 6 months
Lipid Profile
Change in total cholesterol, triglycerides, HDL, LDL and VLDL levels (mg/dl) will be assessed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start8 Jun 2021
- Primary completion25 Feb 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Anuradha Khadilkar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Anuradha Khadilkar, Hirabai Cowasji Jehangir Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900387
- Sponsor's protocol ID
- JCDC/BHR/23/044
- Status last verified
- Mar 2025
- First submitted
- 6 Dec 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Vitamin D3 and Calcium Supplementation on Sarcopenia Indices and Osteoporosis Among Rural Post-menopausal Women
- ClinicalTrials.gov ID
- NCT06900387
- Acronym / sponsor ID
- JCDC/BHR/23/044
- Conditions
- Sarcopenia, Osteoporosis
- Keywords
- Sarcopenia intervention study, sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Dr. Anuradha KhadilkarUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A- Calcium and Vitamin D3 | Active comparator | Dietary Supplement: Tablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month.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. |
| Group B- Vitamin D3 | Active comparator | Dietary Supplement: Tablet Tayo- Vitamin D3 (Cholecalciferol) (60,000 IU) once a month.Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month for the period of 6 months. |
| Group C- Control Group | Active comparator | Other: Control GroupThis was a control group. No additional intervention was given to control group. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy post-menopausal women
- Age between 40-65 years.
Key exclusion criteria (3 listed)
- Women with co-morbidities such as diabetes, thyroid conditions, heart disease, chronic liver/kidney disease, present acute illness
- Presence of any metal implants in bones
- Women who have undergone hysterectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Group A- Calcium and Vitamin D3 |
| 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. | Dietary supplement | Group B- Vitamin D3 |
| Control GroupNo additional intervention was given to control group. | Other | Group C- Control Group |
Primary outcome
Sarcopenia Indices
Time frame: 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
Time frame: 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
3 secondary outcomes
Vitamin D levels
Time frame: 6 months.
Parathyroid Hormone (PTH) levels
Time frame: 6 months
Lipid Profile
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month. and Tablet Tayo- Vitamin D3 (Cholecalciferol) (60,000 IU) once a month. in people with Sarcopenia and Osteoporosis, run by Dr. Anuradha Khadilkar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenia Indices (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.