Vitamin D and aromatase inhibitor-induced musculoskeletal symptoms (AIMSS): a phase II, double-blind, placebo-controlled, randomized trial.

What Was Tested

This randomized controlled trial looks at Vitamin D, K2, Magnesium and Zinc.

Patients with early breast cancer and AIMSS were stratified according to their baseline 25-hydroxy vitamin D (25OHD) level.

The primary endpoint of the study was the change-from-baseline musculoskeletal pain.

Who Took Part

By PubMed's age tags, the people studied were middle-aged adults and older adults, women only.

AIMSS was assessed by the Brief Pain Inventory-Short Form (BPI-SF), the Fibromyalgia Impact Questionnaire (FIQ), and the Health Assessment Questionnaire-Disability Index (HAQ-DI) at baseline, 2, 4, and 6 months.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

A placebo (an inactive look-alike) gave the Vitamin D, K2, Magnesium and Zinc group a baseline to be compared against.

Bone Mineral Density (BMD) was measured at baseline and at 6 months.

What Was Measured

Patients with early breast cancer and AIMSS were stratified according to their baseline 25-hydroxy vitamin D (25OHD) level.

The primary endpoint of the study was the change-from-baseline musculoskeletal pain.

The subject headings attached to it are Anastrozole, Antineoplastic Agents, Hormonal, Aromatase Inhibitors, Bone Density, Bone Density Conservation Agents, Breast Neoplasms and Calcium.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc.

The publication is from 2011 (Breast cancer research and treatment), a journal based in Netherlands.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.