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Asthma attacks reduced in half if Vitamin D level higher than 42 nanograms – RCT May 2014

Effect of Vitamin D3 on Asthma Treatment Failures in Adults With Symptomatic Asthma and Lower Vitamin D Levels: The VIDA Randomized Clinical Trial

JAMA. Published online May 18, 2014. doi:10.1001/jama.2014.5052
Mario Castro, MD, MPH1; Tonya S. King, PhD2; Susan J. Kunselman, MA2; Michael D. Cabana, MD, MPH3; Loren Denlinger, MD, PhD4; Fernando Holguin, MD5; Shamsah D. Kazani, MD6; Wendy C. Moore, MD7; James Moy, MD8; Christine A. Sorkness, PharmD4; Pedro Avila, MD9; Leonard B. Bacharier, MD1; Eugene Bleecker, MD7; Homer A. Boushey, MD3; James Chmiel, MD10; Anne M. Fitzpatrick, PhD11; Deborah Gentile, MD12; Mandeep Hundal, MD13; Elliot Israel, MD6; Monica Kraft, MD13; Jerry A. Krishnan, MD, PhD14; Craig LaForce, MD15; Stephen C. Lazarus, MD3; Robert Lemanske, MD4; Njira Lugogo, MD13; Richard J. Martin, MD16; David T. Mauger, PhD2; Edward Naureckas, MD17; Stephen P. Peters, MD, PhD7; Wanda Phipatanakul, MD, MS18; Loretta G. Que, MD13; Ajay Sheshadri, MD1; Lewis Smith, MD9; Julian Solway, MD17; Lisa Sullivan-Vedder, MD19; Kaharu Sumino, MD, MPH1; Michael E. Wechsler, MD16; Sally Wenzel, MD5; Steven R. White, MD17; E. Rand Sutherland, MD, MPH16,20 ; for the National Heart, Lung, and Blood Institute’s AsthmaNet

Importance In asthma and other diseases, vitamin D insufficiency is associated with adverse outcomes. It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency.

Objective To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels.

Design, Setting, and Participants The VIDA (Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma) randomized, double-blind, parallel, placebo-controlled trial studying adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute’s AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by January 2014. After a run-in period that included treatment with an inhaled corticosteroid, 408 patients were randomized.

Interventions Oral vitamin D3 (100 000 IU once, then 4000 IU/d for 28 weeks; n = 201) or placebo (n = 207) was added to inhaled ciclesonide (320 µg/d). If asthma control was achieved after 12 weeks, ciclesonide was tapered to 160 µg/d for 8 weeks, then to 80 µg/d for 8 weeks if asthma control was maintained.

Main Outcomes and Measures The primary outcome was time to first asthma treatment failure (a composite outcome of decline in lung function and increases in use of β-agonists, systemic corticosteroids, and health care).

Results Treatment with vitamin D3 did not alter the rate of first treatment failure during 28 weeks (28% [95% CI, 21%-34%] with vitamin D3 vs 29% [95% CI, 23%-35%] with placebo; adjusted hazard ratio, 0.9 [95% CI, 0.6-1.3]). Of 14 prespecified secondary outcomes, 9 were analyzed, including asthma exacerbation; of those 9, the only statistically significant outcome was a small difference in the overall dose of ciclesonide required to maintain asthma control (111.3 µg/d [95% CI, 102.2-120.4 µg/d] in the vitamin D3 group vs 126.2 µg/d [95% CI, 117.2-135.3 µg/d] in the placebo group; difference of 14.9 µg/d [95% CI, 2.1-27.7 µg/d]).

Conclusions and Relevance Vitamin D3 did not reduce the rate of first treatment failure or exacerbation in adults with persistent asthma and vitamin D insufficiency. These findings do not support a strategy of therapeutic vitamin D3 supplementation in patients with symptomatic asthma.

Trial Registration clinicaltrials.gov Identifier: NCT01248065

Exploratory Vitamin D3 Responder Analyses (extracted from PDF)

When vitamin D3-treated participants who achieved a 25-hydroxyvitamin D level of 30 ng/mL or greater (n = 157 of 201) were compared with all placebo-treated participants (n = 207), the rate of first treatment failure was not reduced: 25% (95% CI, 18%-32%) vs 29% (95% CI, 23%-35%), respectively, during 28 weeks (adjusted HR, 0.8 [95% CI, 0.5-1.2], P = .20; eTable6 in Supplement). The rate of first exacerbation was lower for the vitamin D3 group (11%; 95% CI, 6%-16%) compared with the placebo group (19%; 95% CI, 13%-24%) (adjusted HR, 0.57 [95% CI, 0.33-0.99], P = .05).
Among participants who responded to treatment, the overall rates were lower for treatment failures (adjusted HR, 0.6 [95% CI, 0.4-0.9], P = .03) and exacerbations (adjusted HR, 0.5 [95% CI, 0.3-0.8], P = .01).
The change in serum 25-hydroxyvitamin D level from baseline to 12 weeks was significantly associated with the rate of treatment failures and exacerbations.
Each 10-ng/mL increase in serum 25-hydroxyvitamin D level was associated with a reduction in the overall rate of treatment failures (HR, 0.88 [95% CI, 0.78-0.99], P = .04) and overall rate of exacerbations (HR, 0.80 [95% CI, 0.67-0.96], P =.02).

PDF is attached at the bottom of this page

Study finds limited benefit for vitamin D in asthma treatment Eurekalert (by the study authors)

  • Started with with an average of 18 nanograms of vitamin D
  • All patients took an inhaled steroid daily to control their asthma,
  • loading dose of 100,000 IU followed by daily doses of 4,000 units,
  • vitamin D group was able to reduce its medication to 111 micrograms per day,
    placebo group was taking an average of 126.
  • 18 % of the treatment group still had blood levels of vitamin D below 30.
    perhaps overweight or obese.
  • Looked at 82 % who increased in their blood vitamin D levels above the critical threshold,
    if > 42 nanograms: improved asthma control.
    40 % fewer treatment failures that required more medication and
    half the number of asthma attacks.

Vitamin D Survivor comment on the study

Which includes

  • I agree with the initial dose of 100,000 IU. However, I do not believe the 4000 IU of D3 was adequate for treatment of asthma. The mean BMI of the test subjects was 32 or borderline obese. It would have been better if the participants were given 10,000 IU of D3 per day to try to get the serum levels of vitamin D > 60 ng/ml. This is the level that most doctors agree is necessary for treating disease and within the clinical standards of 30-100 ng/ml.
  • Also, I would not have given the steroid inhaler to the vitamin D group. I would have used a placebo inhaler.

VitaminDWiki observation

I was concerned that so many reports of this study said that Asthma was not helped by Vitamin D.
Example titles: Vitamin D Flops as Asthma Therapy Booster    Vitamin D supplementation does not improve asthma treatment, symptoms
Vitamin D doesn't benefit asthmatics much    Vitamin D no help in asthma - Medical Observer Study questions role of vitamin D in asthma
Asthma: vitamin D supplements 'do not improve symptoms or treatment'
Those reports ignored those people who actually achieved a useful amount of vitamin D (non obese, etc)
   As can be seen from both the Press Release by the authors and deep inside the study
It is amazing that researchers oten still look only at the dose given, and not the actual response
    the response has been shown to vary by almost 4X between individuals

See also VitaminDWiki

Attached files

ID Name Comment Uploaded Size Downloads
3922 Asthma RCT.pdf admin 20 May, 2014 416.69 Kb 2054