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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

Primary Purpose

Vitamin D Deficiency

Status
Not yet recruiting
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Oral administration of vitamin D3
Vitamin D3 50000 UNT Oral Capsule
milk, Dietary and life style modifications.
Sponsored by
University of Sargodha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Postmenopausal women, Low Bone density

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Postmenopausal Women

Exclusion Criteria:

  • All other women

Sites / Locations

  • Arsalan Khalid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Postmenopausal women with low BMD

Postmenopausal women

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 21, 2022
Last Updated
May 21, 2022
Sponsor
University of Sargodha
Collaborators
Government College University Faisalabad
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1. Study Identification

Unique Protocol Identification Number
NCT05389943
Brief Title
The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density After Orally Vitamin D3 Administration
Official Title
The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 5, 2022 (Anticipated)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sargodha
Collaborators
Government College University Faisalabad

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Postmenopausal women, Low Bone density

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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
ParticipantCare Provider
Masking Description
participants and care giver will be blind in this study
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Postmenopausal women with low BMD
Arm Type
Experimental
Arm 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
Arm Title
Postmenopausal women
Arm Type
Active Comparator
Arm Description
Postmenopausal women having serum 25-hydroxy vitamin D [25(OH)D] greater than 32 ng/ml will provided with milk and dietary modifications.
Intervention Type
Drug
Intervention Name(s)
Oral administration of vitamin D3
Other Intervention Name(s)
Postmenopausal women
Intervention Description
the effect of oral supplement in postmenopausal women.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 50000 UNT Oral Capsule
Intervention Description
In postmenopausal women with BMD less than 32 ng/ml
Intervention Type
Dietary Supplement
Intervention Name(s)
milk, Dietary and life style modifications.
Intervention Description
Postmenopausal women with BMD greater than 32 ng/ml
Primary Outcome Measure Information:
Title
Postmenopausal women BMD will be improved with oral vitamin D supplements
Description
Vitamin D can improve the BMD in women and reduces the risk of infection
Time Frame
3 to 4 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
More than 50 years old
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Postmenopausal Women Exclusion Criteria: All other women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hafiza Saba Javed, EPH
Phone
00923414287908
Email
alizaahemad789@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Arsalan Khalid, MBBS
Phone
00923437693310
Email
irslan3310@gmail.com
Facility Information:
Facility Name
Arsalan Khalid
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
abdul Rauf, FCPS
Phone
+92489232003
Email
rauf.abdul@uos.edu.pk
First Name & Middle Initial & Last Name & Degree
Hafiza Saba Javed, EPH
Phone
00923414287908
Email
alizaahemad789@gmail.com
First Name & Middle Initial & Last Name & Degree
Saba Javed, EPH

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
not decided yet

Learn more about this trial

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

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