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Breast Cancer Trial using monotherapy vitamin D will probably fail – Nov 2021

Assessment the effect of vitamin D supplementation on plasma vitamin D levels, inflammation, and oxidative stress biomarkers based on vitamin D receptor genetic variation in breast cancer survivors: a protocol for clinical trial

Journal of Health, Population and Nutrition volume 40, Article number: 46 (2021)
Elham kazemian, Mohammad Esmaeil Akbari, Nariman Moradi, Safoora Gharibzadeh, Atieh Amouzegar, Laura S. Rozek, Alison M. Mondul, Maryam Khademolmele, Katie R. Zarins, Nasim Ghodoosi, Zahra Shateri, Soudabeh Fallah & Sayed Hossein Davoodi


The item on this page is a Trial Protocol
The Protocol is:

  1. Not giving enough vitamin D (only 4,000 IU daily)
  2. Not giving a different form of vitamin D for those with poor guts
  3. Not giving larger doses to those who are overweight or obese
  4. Not giving vitamin D long enough – only 12 weeks
    • 12 weeks of 4,000 IU will get less tthan half of the women to a level which will show a benefit
    • Would need at least 40 weeks to notice a resulting decrease in parameters to be measured – inflammation, etc.
  5. Considering sunlight exposure in terms of number of hours a day, rather than hours per day near noon
  6. Unlikely to find enough participants who will be willing to give up on proven Vitamin D, Omega-3, and Selenium therapies
  7. Ignoring the type and amount of Breast Cancer Treatment; Chemo, Radiation, Surgery, etc.
  8. IIgnoring number of years since diagnosis:
    • Vitamin D is much better at putting out a small brush fire than a raging forest fire (COVID, etc)

This study almost seems to have a goal of showing that Vitamin D does not help.
It could save lots of lives if instead it:
1) Used a loading dose of vitamin D to get past the Vitamin D Receptor and also speed up the trial
2) Added Omega-3
3) Added Selenium
4) Added activators for the Vitamin D Receptors
5) Increased the dose of vitamin D given based on obesity and pre-existing levels

It has been known for many years that the vitamin D Receptor is extremely important to Breast Cancer

It appears that the Cancer actively decreases the activation of the Vitamin D Receptor

 Download the PDF from VitaminDWiki

Both human genes and environmental exposures, due to complex interplay, play important role in the cancer etiology. Vitamin D is associated with a reduced risk of incidence and mortality of several human cancers. This study will aim to investigate the possible effects of individual polymorphisms in vitamin D receptor (VDR) as well as effects of VDR haplotypes on response to vitamin D supplementation in breast cancer survivors.

This is an interventional study in which the effects of vitamin D supplementation on plasma vitamin D levels, inflammatory and antioxidant biomarkers and factors associated with cell proliferation, differentiation, damage, and apoptosis will be investigated stratified by variations in VDR genotype. The present study will be conducted on breast cancer survivors referred to the Shohadaye Tajrish hospital and its associated clinics. One hundred ninety-eight breast cancer survivors will receive 4000 IU of vitamin D3 daily for 12 weeks. VDR Fok1, ApaI, TaqI, BsmI, and Cdx-2 genotype will be determined at the end of the study and responses to vitamin D supplements (inflammatory, antioxidant, cell proliferation, differentiation, damage, and apoptosis biomarkers) will be compared between the three subgroups of each VDR polymorphism as well as different VDR haplotype categories.

Genetic variation is a fundamental factor influencing individuals’ divergent responses to diet, nutritional status, metabolic response, and diet-related health disorders. Furthermore, studies of gene and environment interactions will provide a precise and accurate assessments of individuals’ dietary requirements by considering both the genetic and environmental aspects simultaneously. The results of the current study, to some extent, will highlight the discrepancies existing in the findings of different studies regarding vitamin D, VDR, and cancer by considering both the genetic and environmental aspects simultaneously. If responses to vitamin D supplementation could be modified by VDR SNPs, determining the distribution of VDR polymorphisms in both breast cancer survivors and healthy populations will provide a new insight into the vitamin D requirements of individuals to prevent cancer and its related mortality based on their genotypes.

Trial registration This trial has been registered on Iranian Registry of Clinical Trials (IRCT) under the identification code: IRCT2017091736244N1, registration date: 2017-11-10, http://www.irct.ir/trial/27153

Created by admin. Last Modification: Tuesday November 2, 2021 21:35:21 GMT-0000 by admin. (Version 6)

Attached files

ID Name Comment Uploaded Size Downloads
16526 BC RCT protocol.pdf admin 02 Nov, 2021 1.15 Mb 251