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

Phase 1

• Conditions: Vitamin D Deficiency
• Interventions: Drug: Oral administration of vitamin D3; Drug: Vitamin D3 50000 UNT Oral Capsule; Dietary Supplement: milk, Dietary and life style modifications.

• Registration Number: NCT05389943
• Lead Sponsor: University of Sargodha

Brief 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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-21
• Study First Submitted QC: 2022-05-21
• Last Update Submitted: 2022-05-21
• Study First Posted: 2022-05-25
• Last Update Posted: 2022-05-25
• Study Start: 2022-06-05
• Primary Completion: 2022-08-15
• Study Completion: 2022-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Postmenopausal Women

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Exclusion Criteria

• All other women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Postmenopausal women with low BMD	Oral administration of vitamin D3	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
Postmenopausal women with low BMD	milk, Dietary and life style modifications.	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
Postmenopausal women with low BMD	Vitamin D3 50000 UNT Oral Capsule	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
Postmenopausal women	milk, Dietary and life style modifications.	Postmenopausal women having serum 25-hydroxy vitamin D \[25(OH)D\] greater than 32 ng/ml will provided with milk and dietary modifications.

Primary Outcome Measures

Name	Time	Method
Postmenopausal women BMD will be improved with oral vitamin D supplements	3 to 4 months	Vitamin D can improve the BMD in women and reduces the risk of infection

Trial Locations

Locations (1)

Arsalan Khalid; 🇵🇰 Faisalābad, Punjab, Pakistan