NCT02507843

Brief Summary

This study evaluates vitamin D as an adjunctive treatment in patients with non-Cystic Fibrosis bronchiectasis, which are combined with vitamin D deficiency. Half of participants will receive vitamin D supplementation, while the other half will receive placebo.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

July 22, 2015

Last Update Submit

July 23, 2015

Conditions

Bronchiectasis

Keywords

Vitamin D

Outcome Measures

Primary Outcomes (1)

  • Time to first acute exacerbation

    one year

Secondary Outcomes (5)

  • total number of exacerbations per group

    one year

  • percentage of patients with one or more exacerbations per year

    one year

  • severity of diseases

    one year

  • using of antibiotics

    one year

  • quality of life

    one year

Study Arms (2)

Vitamin D group

ACTIVE COMPARATOR

Cholecalciferol will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study.

Drug: Cholecalciferol

Placebo group

PLACEBO COMPARATOR

Placebo will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study.

Drug: Placebo

Interventions

CholecalciferolDRUG

Oral Cholecalciferol(100000 IU) will be administered in Vitamin D group monthly for 6 months.

Also known as: Vitamin D3
Vitamin D group
PlaceboDRUG

Placebo will be administered in placebo group monthly for 6 months.

Also known as: Migliol Placebo Oil
Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of non-Cystic fibrosis bronchiectasis by High Resolution CT
  • Age 18 years or older
  • Vitamin D deficiency \[25(OH)D\<20 ng/mL\]
  • Informed consent

You may not qualify if:

  • Current active allergic bronchopulmonary or tuberculosis
  • Diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, Human Immunodeficiency Virus infection, liver failure, renal failure or malignancy
  • 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
  • Treatment with any investigational medical product or device up to 4 months before first dose
  • Breastfeeding, pregnant or planning a pregnancy
  • Baseline corrected serum calcium \> 2.65 mmol/L
  • Baseline serum creatinine \> 125 micromol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital , Tongji University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (3)

  • Chalmers JD, McHugh BJ, Docherty C, Govan JR, Hill AT. Vitamin-D deficiency is associated with chronic bacterial colonisation and disease severity in bronchiectasis. Thorax. 2013 Jan;68(1):39-47. doi: 10.1136/thoraxjnl-2012-202125. Epub 2012 Oct 16.

    PMID: 23076388RESULT

  • Bartley J, Garrett J, Grant CC, Camargo CA Jr. Could vitamin d have a potential anti-inflammatory and anti-infective role in bronchiectasis? Curr Infect Dis Rep. 2013 Apr;15(2):148-57. doi: 10.1007/s11908-013-0321-9.

    PMID: 23371406RESULT

  • Martinez-Garcia MA, de Gracia J, Vendrell Relat M, Giron RM, Maiz Carro L, de la Rosa Carrillo D, Olveira C. Multidimensional approach to non-cystic fibrosis bronchiectasis: the FACED score. Eur Respir J. 2014 May;43(5):1357-67. doi: 10.1183/09031936.00026313. Epub 2013 Nov 14.

    PMID: 24232697RESULT

MeSH Terms

Conditions

Bronchiectasis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • JinFu Xu

    Shanghai Pulmonary Hospital , Tongji University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JinFu Xu

CONTACT

+86-1332192289813321922898@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 24, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

CN(1)