Vitamin D and Calcium Supplementation in Breast Cancer

November 30, 2023 updated by: Mai Abo Elyazeed Hassan Hamouda, Tanta University

Effect of Vitamin D and Calcium Supplementation on Letrozole-induced Musculoskeletal Side Effects in Breast Cancer Egyptian Patients

This study aims at assessing the vitamin Dstatus in breast cancer patients who receive letrozole for more than two months and to evaluate effects of vitamin D3 and calcium supplementation on arthalgia caused by letrozole on these patients.

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, GHR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: Letrozole + vitamin D3 and calcium
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.
Drug: Letrozole 2.5mg
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

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Director: Sahar K Hegazy, Professor, Head of clinical Pharmacy Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin D and breast cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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