- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05523609
Vitamin D and Calcium Supplementation in Breast Cancer
Effect of Vitamin D and Calcium Supplementation on Letrozole-induced Musculoskeletal Side Effects in Breast Cancer Egyptian Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Vitamin D deficiency (< 10 ng/mL) and insufficiency (10-30 ng/mL) may contribute to musculoskeletal symptoms observed in patients taking letrozole. This study was undertaken to assess the vitamin D status in breast cancer patients who received letrozole for > 6 months and to evaluate the effects of vitamin D3 and calcium supplementation on them.
Methods: Forty breast cancer patients were included. They were divided into 2 equal groups: Control group received Letrozole only, and VitD/Ca group received Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks. Baseline serum 25-hydroxy vitamin D concentrations were assayed and standard health assessment questionnaire was completed to assess the disability caused by musculoskeletal symptoms.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Mai A Elgebaly, Pharm D
- Phone Number: 002 01061412257
- Email: dr.mai.elgebaly@gmail.com
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, GHR
- Recruiting
- Tanta Cancer Center
-
Contact:
- Mai A Hamouda, Pharm D
- Phone Number: 01061412257
- Email: pg_55464@pharm.tanta.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Newly diagnosed breast cancer patients.
- Postmenopausal hormone receptor positive.
- Patients receiving letrozole for more than two months
- Gender: Female.
- Age: ≥ 50 years old.
Exclusion Criteria:
- Patients with bone metastasis.
- History of renal stones.
- Serum calcium >11mg/L.
- Patients with renal insufficiency.
- Patients taking steroid hormone replacement therapy.
- Second Malignancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VitD/Ca group
20 patients will receive Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks.
|
20 patients will receive Letrozole in addition to 2000 IU vitamin D3 per day for 12 weeks.
|
Experimental: Control Group
20 patients will receive Letrozole only for 12 weeks.
|
20 patients will receive Letrozole only for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Osteocalcin level
Time Frame: 12 weeks
|
Osteocalcin level at base line and 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sahar K Hegazy, Professor, Head of clinical Pharmacy Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Micronutrients
- Hormone Antagonists
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Vitamin D
- Cholecalciferol
- Letrozole
- Calcium
Other Study ID Numbers
- Vitamin D and breast cancer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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