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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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05389943
Enrollment
80
Registered
2022-05-25
Start date
2022-06-05
Completion date
2022-11-15
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

Postmenopausal women, Low Bone density

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.

Interventions

DRUGOral administration of vitamin D3

the effect of oral supplement in postmenopausal women.

In postmenopausal women with BMD less than 32 ng/ml

DIETARY_SUPPLEMENTmilk, Dietary and life style modifications.

Postmenopausal women with BMD greater than 32 ng/ml

Sponsors

Government College University Faisalabad
CollaboratorOTHER
University of Sargodha
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

participants and care giver will be blind in this study

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.

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Postmenopausal Women

Exclusion criteria

* All other women

Design outcomes

Primary

MeasureTime frameDescription
Postmenopausal women BMD will be improved with oral vitamin D supplements3 to 4 monthsVitamin D can improve the BMD in women and reduces the risk of infection

Countries

Pakistan

Contacts

Primary ContactHafiza Saba Javed, EPH
alizaahemad789@gmail.com00923414287908
Backup ContactArsalan Khalid, MBBS
irslan3310@gmail.com00923437693310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026