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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Letrozole 2.5mg	20 patients will receive Letrozole only 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.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-09-01
• Completion: 2024-10-01
• First posted: 2022-08-31
• Last updated: 2023-12-01

Locations

1 site across 1 country: Egypt