Prevention of COPD exacerbation by normalizing serum vitamin D3 level.

Study of the effect of vitamine D3 on incidence of exacerbations and infections of ‘chronic obstructive pulmonary disease’ patients (COPD) with serum levels of vitamine D less than 75 nmol/L.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016022826816N1

Enrollment

Registered

2016-05-05

Start date

2016-06-20

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease. Chronic obstructive pulmonary disease with acute exacerbation, unspecified

Interventions

Intervention 1: Intervention: administration of Vitamin D3, Control: Placebo. Intervention 2: The control group (Placebo): This group will receive a placebo capsule after lunch on Saturday, each week

Treatment - Drugs

Placebo

Intervention: administration of Vitamin D3, Control: Placebo

The control group (Placebo): This group will receive a placebo capsule after lunch on Saturday, each week for 12 consecutive weeks.

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criterial: All COPD patients including those with emphysema and chronic bronchitis with serum vitamin D-25 level less than 75 nmol/L. Exclusion criterial: 1. patients younger than 40 yrs; 2. patients with FEV1/FVC 70%; 4. patients with history of consumtion of less than 15 pack year cigarettes; 5. patient with asthma or history of asthma; 6. patients with serum level of vitamine D > 75 mnol/L; 7. patients with diabetes, renal failure, history of MI, bronchiectasia, sarcoidosis, hypoparathyroidism, nephrolithiasis, active TB, liver failure, malignancy with remission less than 3 years age; 8. patients under treatment with carbamazepine, cardiac glycosides, phenobarbital, phenytoin, perimidon; 9. patients with serum calcium level above 2.65 mmol/L or serum creatinine level above 125 micromol/L; 10. patients unable to cooperate with spirometery; 11. patient who need to receive more than 12 hrs per day oxygen.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Occurance of an exacerbation of COPD. Timepoint: Monthly. Method of measurement: clinical and paraclinical observations.	—

Secondary

Measure	Time frame
Functional class of the patients. Timepoint: End of the study. Method of measurement: clinical observation and interview.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShirin Izadi

Iran University of Medical Sciences

izadi.sh@iums.ac.ir+98 21 7742 8021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026