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Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease

Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients With Chronic Obstructive Pulmonary Disease

NCT00977873•Barts & The London NHS Trust

View on ClinicalTrials.gov

Summary

The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to moderate/severe exacerbation of chronic obstructive pulmonary disease.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Medical record diagnosis of COPD, emphysema or bronchitis
•Post-bronchodilator FEV1 / FVC \< 70% or post-bronchodilator FEV1 / slow VC \< 70%
•Post-bronchodilator FEV1 \< 80% predicted
•Age ≥ 40 years on day of first dose of IMP
•Smoking history ≥ 15 pack-years
•If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
•Able to give written informed consent to participate

Exclusion Criteria

•Current diagnosis of asthma
•Known clinically significant bronchiectasis
•Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years
•Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
•Taking dietary supplement or topical preparation containing vitamin D up to 2 months before first dose of IMP
•Treatment with any investigational medical product or device up to 4 months before first dose of IMP
•Breastfeeding, pregnant or planning a pregnancy
•Baseline corrected serum calcium \> 2.65 mmol/L
•Baseline serum creatinine \> 125 micromol/L

Locations (4)

Lower Clapton Health Centre

London, United Kingdom

Homerton University Hospital NHS Foundation Trust

London, United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Barts and The London NHS Trust

London, United Kingdom

Key Dates

Start Date

September 1, 2009

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2013

Last Updated

February 4, 2014

Enrollment

240

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Cholecalciferol

DIETARY_SUPPLEMENT

Miglyol oil

DIETARY_SUPPLEMENT

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease

Inclusion Criteria

Exclusion Criteria

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Probiotics in Pulmonaty Rehabilitation for COPD

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

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