CKD: Vitamin D (2018)

Author and Year:
Massart A et al 2014
PubMed ID:
Article Title:
Biochemical parameters after cholecalciferol repletion in hemodialysis: results From the VitaDial randomized trial.
Authors:
Massart A, Debelle F, Racapé J, Gervy C, Husson C, Dhaene M, Wissing K, Nortier J
Journal:
American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation
Year of publication:
2014
Volume:
64
Issue:
5
Page numbers:
696-705
Study Design:
Randomized Controlled Trial
Risk of Bias Assessment Rating:
Neutral
Inclusion Criteria:
Age 18 years and older Receiving HD for at least 3 months with a minimum of three HD sessions weekly Serum 25(OH)D level <30 ng/mL Informed consent
Exclusion Criteria:
Known hypersensitivity to any constituent of the study medications Pregnancy or lactation period Women without effective contraception Cholecalciferol and/or calcitriol and/or paricalcitol and/or alfacalcidol dosage adjustment one month prior to enrollment Plasma calcium level >10.2 mg/dL Concurrent enrollment in another clinical trial (Per the EU clinical trial registry: receipt of investigational compound or treatment 3 months prior to enrollment) Prior parathyroidectomy Granulomatous disorder Active malignancy Estimated life expectancy less than a year
Research Purpose:
The present study, combining a 13-week randomized trial of oral cholecalciferol repletion versus placebo with an open-label study of customized cholecalciferol prescription derived from the NKF-KDOQI guidelines for 26 additional weeks aimed to provide valuable information about vitamin D repletion strategies and their possible impact on mineral and bone markers.
Blinding efforts:
Participants were randomized to either placebo or D3 in a 1:1 ratio. Block randomization with permuted blocks of 4 allocations and stratified by center were used. The placebo and active drug were indistinguishable from each other. Authors did not describe who recruited participants, performed randomization or who assessed outcomes.
Study Location:
Baudour and Brussels, Belgium
Source(s) of Funding:
Industry, University/Hospital
Please specify names of funders:
Genzyme-Sanofi (unrestricted grant) Bristol Myers Squibb provided the cholecalciferol (D-Cure) Erasme Hospital, Universite Libre de Bruxelles, Brussels Centre Hospitalier Epicura, Baudour Universitair Ziekenhuis, Vrije Universiteit Brussel
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
5. Was blinding used to prevent introduction of bias? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? ???
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) Yes
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
7. Were outcomes clearly defined and the measurements valid and reliable? ???
  7.1. Were primary and secondary endpoints described and relevant to the question? ???
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? ???
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? ???
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? Yes
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? No
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes