| Reference ↗
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| Title
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Effects of High-Dose Vitamin D Supplementation on Phase Angle and Physical Function in Patients with Prostate Cancer on ADT
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| Topic
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Vitamin D
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| Author
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Inglis, JE, Fernandez, ID, Van Wijngaarden, E, Culakova, E, Reschke, JE, Kleckner, AS, Lin, P-J, Mustian, KS, Peppone, LJ
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| Year
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2020
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| Journal
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Nutrition and cancer
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| DOI
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https://doi.org/10.1080/01635581.2020.1819348
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Study Note
Brief summary
The 59 patients suffering from prostate cancer and treated with androgen deprivation therapy were randomly divided into two arms. 29 patients received daily high-dose vitamin D and 30 patients received a placebo, and both arms received a multivitamin (low dose of vitamin D and calcium). After 24 weeks, there were small indications that the patients who received high-dose vitamin D might have healthier muscle cells. Over time, androgen deprivation therapy may result in a reduction in lean body mass, which is the lean body mass associated with muscle mass. However, for most tests (e.g. grip strength, leg extension and walking) there were no benefits for the vitamin D arm. The study has a small sample size and gives little information about the patients, which may mean that factors such as cancer stage are not taken into account in the analysis. Also, vitamin D levels are not measured at the end of the study, so it is unclear whether patients remained in deficit.
Die 59, an Prostatakrebs leidenden und mit Androgendeprivationstherapie behandelten Patienten, wurden zufällig in zwei Arme eingeteilt. 29 Patienten erhielten täglich hochdosiertes Vitamin D und 30 Patienten ein Placebo, sowie beide Arme ein Multivitamin (geringe Dosis Vitamin D und Kalzium). Nach 24 Wochen zeigen sich kleine Hinweise darauf, dass die Patienten, die hochdosiertes Vitamin D erhielten, gesündere Muskelzellen haben könnten. Unter der Androgendeprivationstherapie kann im Laufe der Zeit eine Reduktion der Lean body mass auftreten, also der der fettfreien Körpermasse, welche mit der Muskelmasse in Verbindung steht. Jedoch zeigten sich für die meisten Tests (zB. Griffstärke, Beinstreckung und Gehen) keine Vorteile für der Vitamin D Arm. Die Studie hat eine kleine Stichprobe und gibt wenig Informationen über die Patienten, wodurch möglicherweise Faktoren wie Krebsstadium in der Analyse nicht berücksichtigt werden. Auch werden am Ende der Studie keine Vitamin D Spiegel gemessen, so dass unklar ist, ob die Patienten im Defizit verblieben sind.
Study Design
| Prospective / Retrospective Prospective: forward-looking, examples include clinical trials, cohort studies, and long-term observational studies;</br>Retrospective: backward-looking, relying on existing data, examples include case-control studies and retrospective cohort studies
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| Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals
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| Blinding No: Open, all parties are aware of group assignments;</br>Single: one party is unaware of group assignments (generally participants);</br>Double: two parties are unaware of group assignments (generally the participants and the researchers); </br>Triple: concealing group assignment from additional parties
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| Is randomized
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Yes
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| Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control
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No
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| Number of arms
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-999
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Study characteristics
| Inclusion criteria
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| Exclusion criteria
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?
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| N randomized
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-999
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| Analysis PP: Per Protocol analysis, i.e. only participants included who adhered to the study protocol.</br>ITT: Intention-to-treat analysis, i.e. all randomized participants included regardless of any drop-outs or changes in assignment.</br>mITT: modified Intention-to-treat analysis can refer to analyses in which participants with missing outcome data are excluded or it can refer to analyses in which only participants who received at least one treatment dose are included. In this case, participants dropped out of the study prematurely for reasons unrelated to the treatment.
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| Specifications on analyses
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| Countries of data collection
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| LoE Level of evidence
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| Outcome timeline Data collection times
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Characteristics of participants
| Setting Refers to cancer therapy setting.</br>- Curative therapy: aims to completely eradicate a disease and achieve a full recovery; </br>- Neo-adjuvant therapy: form of curative therapy, given before the primary treatment for cancer (usually surgery); </br>- Adjuvant therapy: form of curative therapy, given after the primary treatment for cancer (usually surgery); </br>- Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease; </br>- Active surveillance: involves close monitoring of disease progression without any intervention (typically used for prostate cancer);</br>- No therapy setting: Patients who completed therapy/are currently not in cancer treatment, cancer survivors.
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| Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included
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| Cancer stages Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;</br>Advanced Stage: cancer that has spread beyond its original site, mostly stages III and IV, with stage IV indicating distant metastasis
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| Specifications on cancer stages
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| Comorbidities
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| Current cancer therapies
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| Specifications on cancer therapies
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| Previous cancer therapies
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| Gender
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| Gender specifications
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| Age groups
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| Age groups specification
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Arms
| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Intervention
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| Number of participants (arm) N randomized
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29
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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NA
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| Drop-out reasons
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NA
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| Intervention
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High-dose vitamin D3
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| Dosage and regime
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50,000 IU/ week, over 24 weeks
+ all participants: daily multivitamin containing the RDA for vitamin D: 600 IU/day + 210 mg/day calcium and calcium supplements (800 mg/day)
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| One-time application
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No
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| Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.
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168
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| Side effects / Interactions
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NI
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| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Placebo
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| Number of participants (arm) N randomized
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30
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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NA
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| Drop-out reasons
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NA
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| Intervention
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Placebo (Low-dose vitamin D3)
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| Dosage and regime
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Placebo vitamin D weekly, over 24 weeks
+ all participants: daily multivitamin containing the RDA for vitamin D: 600 IU/day + 210 mg/day calcium and calcium supplements (800 mg/day)
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| One-time application
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No
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| Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.
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168
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| Side effects / Interactions
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NI
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Outcomes
Body composition
| Outcome type As specificed by the authors
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NI
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| Outcome specification
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Phase angle and lean mass
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| Type of measurement
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BIA (Bioelectrical impedance analysis)
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| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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Phase angle: significantly wider phase angle values in intervention arm at week 12 (p=0.014;95% CI -0.824, -0.098) and at week 24 (p=0.018; 95% CI -0.922, -0.090)
Lean mass: significantly higher in intervention arm at week 12 (p=0.036; 95% C.I. 0.229, 6.556) but no significant differences between arms at any other time point
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| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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NI
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
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some concerns
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| Bias due to deviation from intended intervention (assignment to intervention)
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some concerns
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| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
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low risk
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| Bias in measurement of the outcome
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low risk
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| Bias in selection of the reported result
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low risk
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| Other sources of bias
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?
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| Overall RoB judgment
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high risk
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Physical functioning
| Outcome type As specificed by the authors
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NI
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| Outcome specification
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Hand grip, lower body strength, physical performance
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| Type of measurement
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Dynamometer, SPPB (Short Physical Performance Battery), Physical examination
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| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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No significant differences between arms at any time point
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| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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NI
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
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?
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| Bias due to deviation from intended intervention (assignment to intervention)
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| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
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| Bias in measurement of the outcome
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?
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| Bias in selection of the reported result
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?
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| Other sources of bias
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?
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| Overall RoB judgment
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?
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Funding and Conflicts of Interest
| Funding
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| Conflicts of Interest
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?
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Further points for assessing the study
Sample
| Power analysis performed
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| - Sample size corresponds to power analysis
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| - Reasons for insufficient sample size based on power analysis
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| If no power analysis performed: at least moderate sample size (n >= 30 per arm)
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| Ethnicity mentioned
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Alternative Explanation
| Other explanations for an effect besides the investigated intervention
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| - Possibility of attention effects
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| - Possibility of placebo effects
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| - Other reasons
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Statistics
| Correct use of parametric and non-parametric tests Testing for normal distribution only necessary if parametric tests are used, NI: use of parametric tests without report of normal distribution testing
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| Correction for multiple testing
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| Measurement of compliance
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| Consistent reporting in numbers (figures, flowchart, abstract, results)
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| Comprehensive and coherent reporting
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| Cross-over
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| - Sufficient washout period
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| - Tested for carry-over effects
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| - Tested for sequence effects
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Interpretation of results
| Effect sizes reported (clinical vs. statistical significance)
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| Side effects systematically recorded
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| Side effects considered in result interpretation
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| Ethics votum
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Additional Notes
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