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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: Oral administration of vitamin D3
* Drug: Vitamin D3 50000 UNT Oral Capsule
* Dietary Supplement: milk, Dietary and life style modifications.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal Women Exclusion Criteria: All other women

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postmenopausal women with low BMD<br>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 | Drug: Oral administration of vitamin D3<br>* the effect of oral supplement in postmenopausal women.<br>* Other names: Postmenopausal women;Drug: Vitamin D3 50000 UNT Oral Capsule<br>* In postmenopausal women with BMD less than 32 ng/ml<br>Dietary Supplement: milk, Dietary and life style modifications.<br>* Postmenopausal women with BMD greater than 32 ng/ml<br>|
| Active Comparator: Postmenopausal women<br>Postmenopausal women having serum 25-hydroxy vitamin D [25(OH)D] greater than 32 ng/ml will provided with milk and dietary modifications. | Dietary Supplement: milk, Dietary and life style modifications.<br>* Postmenopausal women with BMD greater than 32 ng/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal women, Low Bone density