EAL

CKD: Vitamin D (2018)

Author and Year:

Mager DR et al 2016

PubMed ID:

Article Title:

Vitamin D3 supplementation, bone health and quality of life in adults with diabetes and chronic kidney disease: Results of an open label randomized clinical trial.

Authors:

Mager DR, Jackson ST, Hoffmann MR, J indal K, Senior PA

Journal:

Clinical Nutrition

Year of publication:

2016

Volume:

Issue:

Page numbers:

686-96

Study Design:

Randomized Controlled Trial

Risk of Bias Assessment Rating:

Positive

Inclusion Criteria:

Not Reported - referenced earlier publication from this same study From earlier publication: Adult (18–80 years) patients diagnosed with diabetes (Type 1 and Type 2) and stage 1–4 CKD (Glomerular Filtration Rate (GFR) 15–89 mL/min/1.73 m2)

Exclusion Criteria:

Not Reported - referenced earlier publication from this same study From previous publication: 1) Patients with co-morbid conditions known to affect vitamin D metabolism including gastrointestinal, liver, rheumatoid or bone disorders (e.g. hyperthyroidism, untreated celiac disease, cancer, Paget’s disease, sarcoidosis, malabsorption, etc.). Individuals with severe, permanent vision impairment will be excluded as this will preclude them from reading supplement labels accurately and safely. Pregnant women will be excluded as Dual-energy X-ray Absorptiometry (DXA) scans are not recommended during pregnancy. Patients weighing >136 kg will be excluded as the DXA table cannot accommodate this weight. 2) Patients on drug therapy known to interfere with vitamin D (e.g. oral glucocorticoids, cholestyramine,colestipol, mineral oil, Orlistat, digoxin). 3) Patients on other forms of active D metabolites (e.g. calcitriol, vitamin D2). 4) Patients with stage 5 CKD (GFR <15 mL/min/1.73

Research Purpose:

To compare the impact of daily (2000 IU/d) vs monthly (40,000 IU/mo) vit D3 supplementation over 6 months on markers of vit D status, bone health and quality of life.

Blinding efforts:

Study Location:

Canada

Source(s) of Funding:

Industry, Not-for-profit

Please specify names of funders:

Kidney Foundation of Canada (KFOC120024), Health Canada (Control File Number 148625), Vitamin D supplements provided by Jamieson Natural Sources® Vitamin D 1000 IU Soft gel (NPN 80017530), and EURO-Pharm International Canada Inc.® EURO D 10,000 IU (DIN 02253178). Clinical Trials.gov (NCT01476501)

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?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	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.)	No
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?	Yes
	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?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	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?	Yes
	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)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	No
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	No
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?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes