The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density After Orally Vitamin D3 Administration

NCT ID: NCT05389943

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-05

Study Completion Date

2022-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Randomized control trial on OPD patients (female age above 50) postmenopausal. the effect of vitamin D supplement on these women's bone density.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
participants and care giver will be blind in this study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Postmenopausal women with low BMD

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

Group Type EXPERIMENTAL

Oral administration of vitamin D3

Intervention Type DRUG

the effect of oral supplement in postmenopausal women.

Vitamin D3 50000 UNT Oral Capsule

Intervention Type DRUG

In postmenopausal women with BMD less than 32 ng/ml

milk, Dietary and life style modifications.

Intervention Type DIETARY_SUPPLEMENT

Postmenopausal women with BMD greater than 32 ng/ml

Postmenopausal women

Postmenopausal women having serum 25-hydroxy vitamin D \[25(OH)D\] greater than 32 ng/ml will provided with milk and dietary modifications.

Group Type ACTIVE_COMPARATOR

milk, Dietary and life style modifications.

Intervention Type DIETARY_SUPPLEMENT

Postmenopausal women with BMD greater than 32 ng/ml

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral administration of vitamin D3

the effect of oral supplement in postmenopausal women.

Intervention Type DRUG

Vitamin D3 50000 UNT Oral Capsule

In postmenopausal women with BMD less than 32 ng/ml

Intervention Type DRUG

milk, Dietary and life style modifications.

Postmenopausal women with BMD greater than 32 ng/ml

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Postmenopausal women

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Postmenopausal Women

Exclusion Criteria

* All other women
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Government College University Faisalabad

OTHER

Sponsor Role collaborator

University of Sargodha

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Muhammad irsalan

Medical officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arsalan Khalid

Faisalābad, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hafiza Saba Javed, EPH

Role: CONTACT

00923414287908

Arsalan Khalid, MBBS

Role: CONTACT

00923437693310

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

abdul Rauf, FCPS

Role: primary

+92489232003

Hafiza Saba Javed, EPH

Role: backup

00923414287908

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

USargodha

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Vitamin D Insufficiency
NCT00933244 COMPLETED PHASE4