Vitamin D DeficiencyPhase 1NCT05389943
The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density After Orally Vitamin D3 Administration
A Phase 1 study testing Oral administration of vitamin D3, Vitamin D3 50000 UNT Oral Capsule and milk, Dietary and life style modifications. in people with Vitamin D Deficiency, run by University of Sargodha at 1 site in Pakistan.
Trial summary
a study design based on vitamin D deficiency in postmenopausal women with low bone density. pre-test for BMD will be done then vitamin D oral supplements will be provided for the period of 3 months. Post-test of BMD will explore the results. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Oral administration of vitamin D3, Vitamin D3 50000 UNT Oral Capsule and milk, Dietary and life style modifications.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jun 2022to 15 Nov 2022
- Phase
- Phase 1
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal Women
Who cannot join
- All other women
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Arsalan Khalid
Faisalābad, Punjab Province, 38000
abdul Rauf, FCPS, +92489232003, rauf.abdul@uos.edu.pk
Hafiza Saba Javed, EPH, 00923414287908, alizaahemad789@gmail.com
About this study
Official title: The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density
a study design based on vitamin D deficiency in postmenopausal women with low bone density. pre-test for BMD will be done then vitamin D oral supplements will be provided for the period of 3 months. Post-test of BMD will explore the results.
Read the detailed description
Sample description Study Design Randomized Control Trial. Settings OPD patients Duration 8 months Sample size 200 Masking Single blind (only Participants) Study subjects Routine visit OPD patients with orthopedic problems Sampling techniques RCT will be done by giving vitamin D (pre-test and post-test of BMD will be done .
Inclusion Criteria Female patients above 50 years (Post-menopausal) Exclusion Criteria All other women Study variables : Independent: Vitamin D Data collection will be done through randomized control trial. Patient with age above 50 years female, with menopausal changes. The BMD test will be done in all participants either placebo or actual treated patients to check the effect of vitamin D3 therapy. Treatment plan includes vitamin D3 at 50,000 International Units daily for 15 days then two times a month for four months along with dietary changes which will consider high dose D3 therapy, and low dose vitamin D3 therapy includes dietary changes along with 1000 international units of Vitamin D3 tablet form. Daily white placebo pills to other group of participants. Bone Mineral Density will be observed through pre-test and Post-test.
- Conditions
- Vitamin D Deficiency
- Being tested
- Oral administration of vitamin D3, Vitamin D3 50000 UNT Oral Capsule, milk, Dietary and life style modifications.
- Keywords
- Postmenopausal women, Low Bone density
- Medical subject headings
- Vitamin D Deficiency, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral administration of vitamin D3Drug
Also called Postmenopausal women
the effect of oral supplement in postmenopausal women.
Vitamin D3 50000 UNT Oral CapsuleDrug
In postmenopausal women with BMD less than 32 ng/ml
milk, Dietary and life style modifications.Dietary supplement
Postmenopausal women with BMD greater than 32 ng/ml
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal women with low BMD | Experimental | patient with serum 25-hydroxy vitamin D [25(OH)D] less than 32 ng/ml. Vitamin D3 5000 IU/d per oral for the period of 3 months will be administered Receives: Drug: Oral administration of vitamin D3; Drug: Vitamin D3 50000 UNT Oral Capsule; Dietary Supplement: milk, Dietary and life style modifications. |
| Postmenopausal women | Active comparator | Postmenopausal women having serum 25-hydroxy vitamin D [25(OH)D] greater than 32 ng/ml will provided with milk and dietary modifications. Receives: Dietary Supplement: milk, Dietary and life style modifications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postmenopausal women BMD will be improved with oral vitamin D supplements
Vitamin D can improve the BMD in women and reduces the risk of infection
Measured: 3 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start5 Jun 2022 (estimated)
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Randomized control trial on OPD patients (female age above 50) postmenopausal. the effect of vitamin D supplement on these women's bone density.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sargodha
- Sponsor type
- University, hospital or other
- Collaborators
- Government College University Faisalabad
- Responsible party
- Principal investigator, Muhammad irsalan, University of Sargodha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389943
- Sponsor's protocol ID
- USargodha
- Status last verified
- May 2022
- First submitted
- 21 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density
- ClinicalTrials.gov ID
- NCT05389943
- Acronym / sponsor ID
- USargodha
- Conditions
- Vitamin D Deficiency
- Keywords
- Postmenopausal women, Low Bone density
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of SargodhaUniversity, hospital or other
- Collaborators
- Government College University Faisalabad
- Study start
- 5 Jun 2022 (estimated)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 25 May 2022 (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.
a study design based on vitamin D deficiency in postmenopausal women with low bone density. pre-test for BMD will be done then vitamin D oral supplements will be provided for the period of 3 months. Post-test of BMD will explore the results.
Detailed description
Sample description Study Design Randomized Control Trial. Settings OPD patients Duration 8 months Sample size 200 Masking Single blind (only Participants) Study subjects Routine visit OPD patients with orthopedic problems Sampling techniques RCT will be done by giving vitamin D (pre-test and post-test of BMD will be done .
Inclusion Criteria Female patients above 50 years (Post-menopausal) Exclusion Criteria All other women Study variables : Independent: Vitamin D Data collection will be done through randomized control trial. Patient with age above 50 years female, with menopausal changes. The BMD test will be done in all participants either placebo or actual treated patients to check the effect of vitamin D3 therapy. Treatment plan includes vitamin D3 at 50,000 International Units daily for 15 days then two times a month for four months along with dietary changes which will consider high dose D3 therapy, and low dose vitamin D3 therapy includes dietary changes along with 1000 international units of Vitamin D3 tablet form. Daily white placebo pills to other group of participants. Bone Mineral Density will be observed through pre-test and Post-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized control trial on OPD patients (female age above 50) postmenopausal. the effect of vitamin D supplement on these women's bone density.
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal women with low BMD | Experimental | Drug: Oral administration of vitamin D3, Drug: Vitamin D3 50000 UNT Oral Capsule, Dietary Supplement: milk, Dietary and life style modifications.patient with serum 25-hydroxy vitamin D [25(OH)D] less than 32 ng/ml. Vitamin D3 5000 IU/d per oral for the period of 3 months will be administered |
| Postmenopausal women | Active comparator | Dietary Supplement: milk, Dietary and life style modifications.Postmenopausal women having serum 25-hydroxy vitamin D [25(OH)D] greater than 32 ng/ml will provided with milk and dietary modifications. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal Women
Key exclusion criteria (1 listed)
- All other women
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 |
|---|---|---|
| Oral administration of vitamin D3Also: Postmenopausal womenthe effect of oral supplement in postmenopausal women. | Drug | Postmenopausal women with low BMD |
| Vitamin D3 50000 UNT Oral CapsuleIn postmenopausal women with BMD less than 32 ng/ml | Drug | Postmenopausal women with low BMD |
| milk, Dietary and life style modifications.Postmenopausal women with BMD greater than 32 ng/ml | Dietary supplement | Postmenopausal women, Postmenopausal women with low BMD |
Primary outcome
Postmenopausal women BMD will be improved with oral vitamin D supplements
Time frame: 3 to 4 months
Vitamin D can improve the BMD in women and reduces the risk of infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No. not decided yet
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral administration of vitamin D3, Vitamin D3 50000 UNT Oral Capsule and milk, Dietary and life style modifications. in people with Vitamin D Deficiency, run by University of Sargodha at 1 site in Pakistan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 May 2022. 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 Pakistan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hafiza Saba Javed, EPH (00923414287908, alizaahemad789@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postmenopausal women BMD will be improved with oral vitamin D supplements (time frame: 3 to 4 months). 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 25 May 2022.