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

NCT05389943 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: USargodha
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Postmenopausal women, Low Bone density

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Postmenopausal women with low BMD

EXPERIMENTAL

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

Postmenopausal women

ACTIVE COMPARATOR

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.

Interventions

Oral administration of vitamin D3 DRUG

the effect of oral supplement in postmenopausal women.

Also known as: Postmenopausal women

Postmenopausal women with low BMD

Vitamin D3 50000 UNT Oral Capsule DRUG

In postmenopausal women with BMD less than 32 ng/ml

Postmenopausal women with low BMD

milk, Dietary and life style modifications. DIETARY_SUPPLEMENT

Postmenopausal women with BMD greater than 32 ng/ml

Postmenopausal women; Postmenopausal women with low BMD

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: More than 50 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal Women

You may not qualify if:

• All other women

Sponsors & Collaborators

• Government College University Faisalabad: collaborator
• University of Sargodha: lead

Study Sites (1)

Arsalan Khalid

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Bone Diseases, Metabolic

Interventions

Milk; Diet

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Nutritional Physiological Phenomena

Central Study Contacts

Hafiza Saba Javed, EPH

CONTACT

00923414287908; alizaahemad789@gmail.com

Arsalan Khalid, MBBS

CONTACT

00923437693310; irslan3310@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: participants and care giver will be blind in this study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical officer

Model Details: Randomized control trial on OPD patients (female age above 50) postmenopausal. the effect of vitamin D supplement on these women's bone density.

Study Record Dates

• First Submitted: May 21, 2022
• First Posted: May 25, 2022
• Study Start: June 5, 2022
• Primary Completion: August 15, 2022
• Study Completion: November 15, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)