NCT06642428 Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer
| NCT ID | NCT06642428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jiuda Zhao |
| Condition | Vitamin D |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-10-18 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2024-10-18 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized controlled Phase III trial was designed to evaluate the impact of supplemental vitamin D (VD) on the efficacy and side effects of neoadjuvant therapy in patients with breast cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 2. Primary diagnosis of breast cancer confirmed by preoperative pathological examination. 3. Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L). 4. Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of 5.neoadjuvant chemotherapy or combined targeted therapy. 6.Life expectancy of at least 6 months. 7.No other uncontrolled benign diseases at the time of recruitment. 8.All patients must have complete clinical medical records. 9.Willingness to voluntarily sign an informed consent form. Exclusion Criteria: 1. History of invasive breast cancer. 2. Prior systemic treatment for the treatment or prevention of breast cancer. 3. Known allergic reactions to vitamin D or calcium compounds. 4. Comorbidities that may affect vitamin D or calcium balance or bone health. 5. Vitamin D or calcium supplementation in the past 3 months. 6. Presence of other tumors. 7. Pregnant or lactating women. 8. Individuals who do not wish to participate in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06642428 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Vitamin D. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06642428 currently recruiting?
Yes, NCT06642428 is actively recruiting participants. Contact the research team at jiudazhao@126.com for enrollment information.
Where is the NCT06642428 trial being conducted?
This trial is being conducted at Xining, China, Xining, China.
Who is sponsoring the NCT06642428 clinical trial?
NCT06642428 is sponsored by Jiuda Zhao. The trial plans to enroll 140 participants.