ClinicalTrials.Veeva

Menu

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

U

University of Sargodha

Status and phase

Unknown
Phase 1

Conditions

Vitamin D Deficiency

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05389943
USargodha

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

Female

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Postmenopausal Women

Exclusion criteria

  • All other women

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

80 participants in 2 patient groups

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

Trial contacts and locations

1

Loading...

Central trial contact

Hafiza Saba Javed, EPH; Arsalan Khalid, MBBS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems