Vitamin D Regulates the Expression of Glucocorticoid Receptors in Blood of Severe Asthmatic Patients (VitaminD)

Dubai Health Authority

Status: Completed

Conditions: Effect of Drug

Treatments: Other: Placebo; Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT04443387

MRC-04/2012_06

Details and patient eligibility

About

Vitamin D (VitD) deficiency is a significant public health concern in many areas around the globe which has been associated with many immune-mediated diseases, including asthma. Severe asthma has been linked with a decreased glucocorticoid receptors (GR) ratio (GR-α/ GR-β ratio), indicating steroid hyporesponsiveness. Using combined in silico and in vivo approaches, aimed to explore the immunomodulatory effect of VitD on asthmatic patients diagnosed with hypovitaminosis D.

Full description

Vitamin D (VitD) deficiency is a significant public health concern in many areas around the globe which has been associated with many immune-mediated diseases, including asthma. Severe asthma has been linked with a decreased glucocorticoid receptors (GR) ratio (GR-α/ GR-β ratio), indicating steroid hyporesponsiveness. Using combined in silico and in vivo approaches, the investigators aimed to explore the immunomodulatory effect of VitD on asthmatic patients diagnosed with hypovitaminosis D. Methods: In silico tools were used to identify the regulatory effect of VitD supplementation on GR genes. The investigators measured the expression levels of GR-α and the inactive isoform, GR-β, in the blood of adult asthmatics diagnosed with hypovitaminosis D before and after VitD supplementation. Moreover, the blood levels of inflammatory cytokines associated with asthma severity were determined.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of asthma
• age group between 18 and 65 years
• low level of 25-hydroxyvitamin D3 (25 D3) level less than 20ng/mL

Exclusion criteria

• smoker patients
• less than 18 years old
• patient on Vitamin D supplementation already

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups, including a placebo group

Asthmatic low vitamin D on treatment

Active Comparator group

Description:

asthmatic patient low vitamin D level received treatment for Vitamin D 50000IU weekly

Treatment:

Drug: Vitamin D

Asthmatic low vitamin D on placepo

Placebo Comparator group

Description:

asthmatic patient low vitamin D level received placepo

Treatment:

Other: Placebo