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QUALITY of INTERVENTIONAL STUDIES

UI Author Year Design * Appropriate Randomization Technique (y/n/nd/NA) Allocation Concealment (y/n/nd/NA) Appropriate Washout Period (y/n/nd/NA) Dropout Rate <20% Blinded Outcome Assessment (y/n/nd) Intention to Treat Analysis (y/n/nd) Appropriate Statistical Analysis ** (y/n) Assessment for Confounding (y/n/nd/NA) Clear Reporting with No Discrepancies (y/n) OVERALL Grade
18089701 Zhu 2008 RCT-parallel Y Y NA Y Y Y Y Y Y B
Adverse Event(s): ** No significant differences among the three groups in the rate of incident cancer or vascular disease. No case of kidney stones was reported.
Explanation for Overall Quality Grade (if not Grade A): Differential dropout rates between groups. During the study, 2 patients withdrew from the Ca group, 6 from CaD group, and 5 from the control group. The reasons for the two withdrawals in the Ca group were concurrent illnesses or health concerns; in the CaD group, the reasons for withdrawal were personal reasons not related to the study (n=3), concurrent illnesses or health concerns (n=2), and investigator’s decision (n =1). In the control group, the r easons for withdrawal were personal reasons not related to the study (n=1), death (n=2), and investigator’s decision (n=2).
Not sure if all subjects had hip BMD measurements (not shown in table or figure, but assumed complete data for BMD in this data extraction form
(excluding withdraws). ITT analyses.
Not all subjects had 25(OH)D data. Crude analysis for curve 4 data only. Grade C for curve 4 data.
No information on food composition database

NA=not applicable

*

Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail)

**

Please do not leave blank. Type nd if there was no data on adverse.

Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail)

Please do not leave blank. Type nd if there was no data on adverse.

From: Appendix C, Evidence Tables: R-Z

Cover of Vitamin D and Calcium
Vitamin D and Calcium: A Systematic Review of Health Outcomes.
Evidence Reports/Technology Assessments, No. 183.
Chung M, Balk EM, Brendel M, et al.

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