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NCT05389943 Clinical Trial

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

Vitamin D Deficiency Clinical Trial

Official title:
The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05389943
Other study ID # USargodha
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date June 5, 2022
Est. completion date November 15, 2022

Study information
Verified date May 2022
Source University of Sargodha
Contact Hafiza Saba Javed, EPH
Phone 00923414287908
Email alizaahemad789@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date November 15, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years and older
Eligibility Inclusion Criteria: - Postmenopausal Women Exclusion Criteria: - All other women

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oral administration of vitamin D3
the effect of oral supplement in postmenopausal women.
• Vitamin D3 50000 UNT Oral Capsule
In postmenopausal women with BMD less than 32 ng/ml
Dietary Supplement:
• milk, Dietary and life style modifications.
Postmenopausal women with BMD greater than 32 ng/ml

Locations
Country Name City State
Pakistan Arsalan Khalid Faisalabad Punjab

Sponsors (2)
Lead Sponsor Collaborator
University of Sargodha Government College University Faisalabad

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 3 to 4 months
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