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Randomized Controlled Trial
. 2021 Aug 18;106(9):2767-2778.
doi: 10.1210/clinem/dgab153.

Vitamin D Supplementation for Prevention of Cancer: The D2d Cancer Outcomes (D2dCA) Ancillary Study

Ranee Chatterjee  1 , Paul Fuss  2 , Ellen M Vickery  2 , Erin S LeBlanc  3 , Patricia R Sheehan  2   4   5 , Michael R Lewis  6 , Rowena J Dolor  1 , Karen C Johnson  7 , Sangeeta R Kashyap  8 , Jason Nelson  9 , Anastassios G Pittas  2 ; D2d Research Group
Collaborators, Affiliations
Randomized Controlled Trial

Vitamin D Supplementation for Prevention of Cancer: The D2d Cancer Outcomes (D2dCA) Ancillary Study

Ranee Chatterjee et al. J Clin Endocrinol Metab. .

Abstract

Context: Observational studies suggest that low vitamin D status may be a risk factor for cancer.

Objective: In a population with prediabetes and overweight/obesity that is at higher risk of cancer than the general population, we sought to determine if vitamin D supplementation lowers the risk of cancer and precancers.

Methods: The Vitamin D and type 2 diabetes (D2d) cancer outcomes study (D2dCA) is an ancillary study to the D2d study, which was conducted at 22 academic medical centers in the United States. Participants had prediabetes and overweight/obesity and were free of cancer for the previous 5 years. Participants were randomized to receive vitamin D3 4000 IU daily or placebo. At scheduled study visits (4 times/year), cancer and precancer events were identified by questionnaires. Clinical data were collected and adjudicated for all reported events. Cox proportional hazard models compared the hazard ratio (HR) of incident cancers and precancers between groups.

Results: Over a median follow-up period of 2.9 years, among 2385 participants (mean age 60 years and 25-hydroxyvitamin D 28 ng/mL), there were 89 cases of cancer. The HR of incident cancer for vitamin D vs placebo was 1.07 (95% CI 0.70, 1.62). Of 241 participants with incident precancers, 239 had colorectal adenomatous polyps. The HR for colorectal polyps for vitamin D vs placebo was 0.83 (95% CI 0.64, 1.07).

Conclusion: In the D2d population of participants with prediabetes and overweight/obesity, not selected for vitamin D insufficiency, vitamin D supplementation did not have a significant effect on risk of incident cancer or colorectal polyps.

Trial registration: ClinicalTrials.gov NCT01942694.

Keywords: cancer; clinical trial; colorectal polyps; prediabetes; vitamin D.

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Figures

Figure 1.
Figure 1.
Flow of participants through the D2dCA study. a One participant did not receive study pills because the participant was randomized with Urine Albumin Creatinine Ratio above the eligibility safety threshold. b Participants did not consent to the D2d cancer ancillary study because the cancer protocol was not approved at two sites.
Figure 2.
Figure 2.
Subgroup analyses: incidence of cancer. All hazard ratios are adjusted for stratification variables [site, BMI (<30 or ≥30) and race (white or non-white)] P > .05 for the interaction terms for all subgroups.
Figure 3.
Figure 3.
Subgroup analyses: risk of colorectal adenomatous polyps. All hazard ratios are adjusted for stratification variables [site, BMI (<30 or ≥30) and race (white or non-white)] P > .05 for the interaction terms for all subgroups.
See this image and copyright information in PMC

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