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
19221190 LaCroix, 2009 RCT-Parallel y y n y nd y y y y B
Adverse Event(s): ** Nd (Study pills were discontinued if women reported kidney stones, hypercalcemia, dialysis, or the use of calcitriol or daily supplements of more than 1,000 IU of vitamin D during semiannual contacts.)
Explanation for Overall Quality Grade (if not Grade A): It was the consensus among the Tufts EPC that overall, the methodological quality of the trial was B, particularly when the trial is being used to guide decisions about DRI, as opposed to decisions about whether to actively recommend supplementation for an individual woman.

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 events.

From: Appendix C, Evidence Tables: L-Q

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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