NCT05389943

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Sargodha · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Oral administration of vitamin D3	the effect of oral supplement in postmenopausal women.
DRUG	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

Timeline

• Start date: 2022-06-05
• Primary completion: 2022-08-15
• Completion: 2022-11-15
• First posted: 2022-05-25
• Last updated: 2022-05-25

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated drug study