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RCT: Vitamin D may help heal leg ulcers

Posted on: December 19, 2012   by  Brant Cebulla


A new randomized controlled trial out of Brazil suggests that vitamin D may help in healing leg ulcers.

The study, led by Claudine Juliana Burkiewicz and colleagues out of Evangelical University Hospital of Curitiba, examined whether vitamin D had any beneficial effect on the healing of leg ulcers versus placebo.

Ulcers are wounds or open sores that will not heal or keep returning. A number of comorbidities like poor circulation, high blood pressure, diabetes and other conditions that impair blood circulation can cause them. For most patients, ulcers are treated inadequately, with nearly half of cases lasting a year and nearly 40% of cases lasting between two to ten years. Here, the authors studied venous ulcers, which account for 80 to 90 percent of all leg ulcers and affect over a half-million people in the United States every year. Traditional treatments include leg compression and topical dressings, as well as casts.

The researchers believed that vitamin D could play a role because of its regulatory effect on keratinocytes, which can affect wound healing. Keratinocytes are the predominate cells on the skin’s outermost layer, and vitamin D plays a significant hand in the growth and differentiation of these cells.

The researchers recruited 26 patients with chronic leg ulcers. They also recruited 26 patients without leg ulcers to act as controls, to see how the group with leg ulcers looked in comparison. The researchers found that the vitamin D levels in ulcer patients was a median 17.1 ng/ml compared to 22.8 ng/ml in the control group.

The 26 ulcer patients were then screened (4 did not meet inclusion criteria) and then randomized to receive either vitamin D at 50,000 IU/week or placebo for two months. Nine patients received placebo, thirteen received the vitamin D. There was no mention of whether the vitamin D was D3 or D2.

Here is what they found:

  • The researchers did not observe a statistically significant difference in ulcer size between the two groups after the course of vitamin D or placebo treatment.

However, when analyzing the change in ulcer size pre and post treatment, here is what they found:

  • Vitamin D decreased the size of ulcers in the vitamin D group by a median .75cm2.
  • The placebo group experienced a median increase of 4cm2.
  • These finding weren’t quite statistically significant (p=.06), but trending.

Limitations of their findings are small number of subjects and small length of study. These short comings could explain their inability to reach statistical significance, but they also leave open the possibility that the “trending” observed was by chance. Put bluntly, the authors state, “Replacement of vitamin D in deficient individuals did not accelerate healing of ulcers, although it displayed a tendency to do so.”

They also note:

“Presently, venous ulcers have no effective therapeutic options and have a high treatment cost due to very slow healing…The study of vitamin D as a potential treatment can be a worthwhile innovation.”

For the time being, this study gives some reason to make sure patients with leg ulcers are sufficient in vitamin D, and it also paves the way for more research in the area.


Burkiewicz CJ et al. Vitamin D and skin repair: a prospective, double-blind and placebo controlled study in the healing of leg ulcers. Revista do Colégio Brasileiro de Cirurgiões, 2012.

Cleveland Clinic. Lower Extremity (Leg and Foot) Ulcers. 2010

8 Responses to RCT: Vitamin D may help heal leg ulcers

  1. [email protected]

    Their data actually showed that the ulcers of the vitamin D group healed 4X faster than the placebo group. The description seems to have gotten scrambled in translation, but the data shows a 38% reduction of ulcer size in the vitamin D group but only a 9% reduction in the placebo group. Details, along with previous paper on the same study are at http://is.gd/ulcersd

  2. Brant Cebulla

    Henry, I think the translation was fine. Since they were working in medians and not means, really have to dig into the results.

    In the vitamin D group, the median size of ulcer started at 25cm2, then reduced to a median 18cm2. For placebo group, the numbers were 27cm2 to 24.5cm2, respectively. I think this is where you’re getting your 38% and 9%. However, these findings were not statistically significant (p=.71, .79), so I think it’s unfair to make too much of total reduction in ulcer size.

    When the researchers analyzed patients on a case-by-case basis, measuring ulcer size pre-treatment and post-treatment, the median patient’s ulcer size decreased by 4cm2 in the vitamin D group, the median patient’s ulcer size increased by .75cm2 in the placebo group. The statistical significance was much better here (p=.06, considered “trending”).

    Also, not sure where you’re pulling the “4x faster” number from? Since we do not know if either groups’ ulcers fully healed (in a condition that may take several years to treat), I’m not sure how you would arrive at “4x faster treatment”, as that somewhat implies that both the vitamin D group and ulcer group were well on their way to recovery, when we don’t know that to be the case.

  3. silvalli

    They should have reported the D level at the end of the study; they should have done a dose-dependent study going up to 50,000IU per day; and they should have administered the D daily.

  4. Brant Cebulla

    silvalli, I think for a pilot study, this was great. For there being little research in the area, it would have been hard justifying more study numbers and a more extensive and complicated protocol.

  5. [email protected]

    Brant, I am not sure I follow you here. In Sweden we use centimeter, cm and 25 cm is very much being a diameter of an ulcer. “median size of ulcer started at 25cm”

    To get cm -> inch x 2.54=cm – to get inch -> cm x 0.39 = inch

    Could be a matter of translation again or converting?

  6. Brant Cebulla

    This study also used the metric system, and I believe I reported as such?

  7. [email protected]

    Brant, sorry, I have to insist, something is wrong. I don´t think I ever saw a leg ulcer as big as 25 cm in diameter, means 9.8 inches diameter. I once worked in a ward where some kind of skin transplants to heal leg ulcers were made. Is it even possible to heal a leg ulcer of that enormous size, as 25 cm diameter?

    When I read the study, I read square-cm, cm2. They count area, not diameter. A 25 cm2 ulcer is a pretty big one, but I have seen them. Now it makes more sense to me. But I have to admit, everytime I see inches, galons or whatever, I still have to look it up, to be sure I get it right. It is too bad we cannot have the same measurement system in the world.

  8. Brant Cebulla

    Ah, yes, you are correct. It is area, not diameter.

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