The Effect of Vitamin D Supplementation on Improvement of Symptoms in Mild-to-Moderate Asthma Patients with Vitamin D Insufficiency and Deficiency

Evaluation of the effect of vitamin D supplementation on improvement of symptoms in mild-to-moderate asthma patients with vitamin D insufficiency and deficiency

A randomized double-blinding clinical trial, with the parallel groups

This clinical trial is carried out in the pulmonary clinic of Al-Zahra Hospital in Isfahan and 132 patients with asthma and vitamin D deficiency/insufficiency will be randomly divided into four parallel groups. Then, two of these four groups will receive the placebo and the other two groups will receive vitamin D supplements.

Inclusion criteria include patients with mild to moderate asthma and vitamin D deficiency/insufficiency. Exclusion criteria include diagnosis of COPD, sarcoidosis, hyperthyroidism, kidney stones, active tuberculosis, vitamin intolerance, liver failure, renal failure, lymphoma, or other malignant tumors have not improved in more than two years. , or treatment with anticonvulsants, vitamin D supplements, treatment with systemic corticosteroids for more than 3 months before the study, breastfeeding or pregnancy, serum calcium above 2.65 mmol/L, exacerbation of asthma in the three months, and active/inactive smoking.

Patients with asthma with vitamin D insufficiency/deficiency receive commonly used asthma control medications (inhaled sprays), which will be the same in both groups. For patients with vitamin D deficiency, in the case group, 50,000 u of vitamin D supplements will be given orally every week for up to 6 weeks and then 1000 U every 4 weeks. Patients with inadequate vitamin D levels will also be prescribed 1000 U every 4 weeks. In the control group with a deficiency/insufficient level of vitamin D, the placebo will be prescribed.

Severity of asthma symptoms; FEV1 parameters; FVC; Vitamin D level (25 OHD)

66 patients with asthma and vitamin D deficiency and also 66 patients with asthma and insufficient levels of vitamin D will be selected using simple randomization. These two groups of 66 people are then coded with the aid of random allocation software and are automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly studied in one of the two groups.

To blind the study, vitamin D and placebo will be prepared in the same shape and color by the pharmacist before the intervention. These drugs will then be coded and made available to the researcher. They also prescribe them without knowing the type of any of the drugs. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.

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