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

Sponsor
University of Sargodha (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05389943
Collaborator
Government College University Faisalabad (Other)
80
Enrollment
1
Location
2
Arms
5.4
Anticipated Duration (Months)
14.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral administration of vitamin D3
  • Drug: Vitamin D3 50000 UNT Oral Capsule
  • Dietary Supplement: milk, Dietary and life style modifications.
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention 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.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 (Participant, Care Provider)
Masking Description:
participants and care giver will be blind in this study
Primary Purpose:
Treatment
Official Title:
The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density
Anticipated Study Start Date :
Jun 5, 2022
Anticipated Primary Completion Date :
Aug 15, 2022
Anticipated Study Completion Date :
Nov 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Postmenopausal women with low BMD

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
the effect of oral supplement in postmenopausal women.
Other Names:
  • 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
    Active Comparator: Postmenopausal women

    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.
    Postmenopausal women with BMD greater than 32 ng/ml

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Postmenopausal Women
    Exclusion Criteria:
    • All other women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arsalan Khalid Faisalābad Punjab Pakistan 38000

    Sponsors and Collaborators

    • University of Sargodha
    • Government College University Faisalabad

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Muhammad irsalan, Medical officer, University of Sargodha
    ClinicalTrials.gov Identifier:
    NCT05389943
    Other Study ID Numbers:
    • USargodha
    First Posted:
    May 25, 2022
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Muhammad irsalan, Medical officer, University of Sargodha
    Postmenopausal women, Low Bone density
    Additional relevant MeSH terms:
    Vitamin D Deficiency
    Vitamin D
    Ergocalciferols
    Cholecalciferol
    Vitamins

    Study Results

    No Results Posted as of May 25, 2022