Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer (OPTIVIT)
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|ClinicalTrials.gov Identifier: NCT04091178|
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
An open clinical trial not randomized, multicentric. This study search to evaluate vitamin D supplementation efficacy at high dose (UVEDOSE, colecalciferol, oral solution at 100 000 UI) of vitamin D on day 1 of each cycles for breast cancer treated adjuvant chemotherapy.
A calcium supplementation will be prescribed in parallel.
An initial dosage of 25OH vitamin D rate will be done and a vitamin-calcic dosage will done on day 1 of every cycles of chemotherapy
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Dietary Supplement: VITAMIN D||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A phase 2 clinical trial not randomized|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A PHASE II Multicentric Trial Evaluating a High Dose Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer Treated by Adjuvant Chemotherapy|
|Actual Study Start Date :||October 10, 2013|
|Actual Primary Completion Date :||June 11, 2015|
|Actual Study Completion Date :||March 16, 2017|
Experimental: VITAMIN D SUPPLEMENTATION ARM
On day 1 of every chemotherapy cycle, the patient will be receive an oral solution of vitamin D (UVEDOSE/calciferol).
In parallel,a calcium supplementation is prescribed.
Dietary Supplement: VITAMIN D
ORAL SOLUTION (2 ml) at 100.000 UI
- Normalisation of Vitamin D level [ Time Frame: from the Cycle 1 to cycle 6 (each cycle is 21 days) ]percentage of vitamin D level normalisation
- initial vitamin D and calcium level [ Time Frame: at cycle 1( one cycle is 21 days) ]blood test
- normalization of 25-OHD (vitamin D) [ Time Frame: at FU 6,12,18,24 months after the first dose of vitamin D ]blood test
- adverses events rates [ Time Frame: from cycle 1 to follow-up 24 months (one cycle is 21 days) ]graded based on NCI-CTCAE v4.03
- vitamin D and calcium level [ Time Frame: from cycle 1 to 24 months (one cycle is 21 days) ]blood test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091178
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Study Chair:||WILLIAM JACOT, MD||Institut régional du cancer de Montpellier|