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

University of Sargodha

Status and phase: Unknown; Phase 1

Conditions: Vitamin D Deficiency

Treatments: Drug: Vitamin D3 50000 UNT Oral Capsule; Dietary Supplement: milk, Dietary and life style modifications.; Drug: Oral administration of vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT05389943

USargodha

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Postmenopausal Women

Exclusion criteria

• All other women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Postmenopausal women with low BMD

Experimental group

Description:

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

Treatment:

Dietary Supplement: milk, Dietary and life style modifications.

Drug: Oral administration of vitamin D3

Drug: Vitamin D3 50000 UNT Oral Capsule

Postmenopausal women

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: milk, Dietary and life style modifications.