Vitamin D Supplementation Improves Pathological Complete Response in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy: A Randomized Clinical Trial

Omodei et al., 2025 | Nutr Cancer | Rct

Citation

Omodei Michelle Sako, Chimicoviaki Jackeline, ... Nahas Eliana Aguiar Petri. Vitamin D Supplementation Improves Pathological Complete Response in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy: A Randomized Clinical Trial. Nutr Cancer. 2025;77(6):648-657. doi:10.1080/01635581.2025.2480854

Abstract

UNLABELLED: This study aimed to evaluate the effect of vitamin D (VD) supplementation on the pathological complete response (pCR) rate in women with breast cancer (BC) undergoing neoadjuvant chemotherapy (NCT). A randomized clinical trial was conducted with 80 women aged ≥45years with BC who were eligible for NCT. Women were randomized into two groups: VD group, daily supplementation with 2,000IU of cholecalciferol (n = 40) or placebo (n = 40), for 6 months. The primary outcome measure was the pCR rate. Serum 25-hydroxyvitamin-D [25(OH)D] levels were measured after BC diagnosis and the end of NCT. Of the 80 randomized women, 75 completed the NCT and underwent surgery. Baseline 25(OH)D values indicated hypovitaminosis D in both groups (VD: 19.6 ± 5.8 ng/mL and placebo: 21 ± 7.9 ng/mL, p = 0.33). After 6 months, 25(OH)D levels increased in the VD group compared to the placebo group (28 ± 8.7 vs. 20.2 ± 6.1 ng/mL, p = 0.03). The pCR rate was higher in women supplemented with VD when compared than the placebo (43% vs. 24%, p = 0.04). Adjusted logistic regression showed that women with 25(OH)D levels ≥20ng/mL were more likely to achieve pCR (OR3.65, 95%CI 1.09-12.8, p = 0.04). Women with BC undergoing NCT who received supplementation with 2,000IU of VD were more likely to achieve a pathological complete response than women in the placebo group. TRIAL REGISTRATION: Ensaiosclinicos.gov.br, identifier RBR-10k4gqdg.

Key Findings

Women with BC undergoing NCT who received supplementation with 2,000IU of VD were more likely to achieve a pathological complete response than women in the placebo group. TRIAL REGISTRATION: Ensaiosclinicos.gov.br, identifier RBR-10k4gqdg.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size 40
Age Range See abstract
Condition See abstract

MeSH Terms

  • Humans
  • Female
  • Breast Neoplasms
  • Neoadjuvant Therapy
  • Middle Aged
  • Vitamin D
  • Dietary Supplements
  • Aged
  • Cholecalciferol
  • Double-Blind Method
  • Treatment Outcome
  • Vitamin D Deficiency

Evidence Classification

  • Level: Rct
  • Publication Types: Journal Article, Randomized Controlled Trial
  • Vertical: vitamin-d-cancer

Provenance


Source extracted via PubMed E-utilities API on 2026-04-09