MAGnesium-oral supplementation to reduce PAin in patients with severe PERipheral arterial occlusive disease: the MAG-PAPER randomised clinical trial protocol.

What Was Tested

Researchers studied Vitamin D, K2, Magnesium and Zinc in this randomized controlled trial publication.

Magnesium exerts analgaesic effects in several animal pain models, as well as in patients affected by acute postoperative pain and neuropathic chronic pain.

There is no evidence that magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD).

Who Took Part

The study group was 150 patients.

The age groups tagged for this paper are teenagers, young adults, adults, middle-aged adults, older adults and people over 80, both men and women.

Adult patients affected by PAOD at stages III and IV of Lèriche-Fontaine classification, who are opioid-naïve, and who have been admitted to their Acute Pain Service for intractable pain, will be eligible.

A sample size calculation was performed for the primary outcome, which estimated a required sample size of 150 patients (75 per group).

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

The patients were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.

Neither the patients nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Vitamin D, K2, Magnesium and Zinc could be set against what happens without it.

What Was Measured

Topics PubMed links to this paper include Analgesics, Opioid, Arterial Occlusive Diseases, Italy, Linear Models, Magnesium, Oxycodone and Pain.

Author keywords: VASCULAR MEDICINE and VASCULAR SURGERY.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc in 150 patients.

The publication is from 2015 (BMJ open), a journal based in England.

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