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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: Oral administration of vitamin D3; Drug: Vitamin D3 50000 UNT Oral Capsule; Dietary supplement: milk, Dietary and life style modifications.

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hafiza Saba Javed, EPH; Phone Number: 00923414287908; Email: alizaahemad789@gmail.com
• Study Contact Backup: Name: Arsalan Khalid, MBBS; Phone Number: 00923437693310; Email: irslan3310@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Faisalābad, Punjab, Pakistan, 38000
      • Arsalan Khalid
      • Contact: Hafiza Saba Javed, EPH; Phone Number: 00923414287908; Email: alizaahemad789@gmail.com
      • Contact: abdul Rauf, FCPS; Phone Number: +92489232003; Email: rauf.abdul@uos.edu.pk
      • Principal Investigator: Saba Javed, EPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Postmenopausal Women

Exclusion Criteria:

• All other women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sargodha
• Collaborators: Government College University Faisalabad

Study record dates

Study Major Dates

• Study Start (Anticipated): June 5, 2022
• Primary Completion (Anticipated): August 15, 2022
• Study Completion (Anticipated): November 15, 2022

Study Registration Dates

• First Submitted: May 21, 2022
• First Submitted That Met QC Criteria: May 21, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 21, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Postmenopausal women, Low Bone density
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: USargodha

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not decided yet

Drug and device information, study documents

• 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