NCT00685971

Brief Summary

The main aim of the research question to test the primary hypothesis of this study, namely, Does 12 weeks of an additional 5000 IU daily of cholecalciferol increase serum 25OHD levels in adults with Cystic Fibrosis (CF) who have vitamin D deficiency relative to placebo?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 21, 2014

Status Verified

July 1, 2011

Enrollment Period

4.6 years

First QC Date

May 27, 2008

Last Update Submit

November 20, 2014

Conditions

Cystic FibrosisVitamin D Deficiency

Keywords

Cystic FibrosisVitamin D deficiency

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure for this study is the change in mean serum 25OHD levels between the two groups

    12 weeks

Secondary Outcomes (6)

  • Mean change from baseline for pulmonary function testing (FEV1 and FVC)

    12 weeks

  • Mean change from baseline in serum calcium levels

    12 weeks

  • Mean change from baseline in parathyroid hormone levels

    12 weeks

  • Mean change from baseline in creatinine levels

    12 weeks

  • Change in the proportion of subjects whose 25OHD vitamin levels are above 75 nmol/L

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Vitamin D

EXPERIMENTAL

vitamin

Dietary Supplement: 5000 IU of cholecalciferol

Placebo

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

5000 IU of cholecalciferolDIETARY_SUPPLEMENT

5 drops taken once daily for 12 weeks

Vitamin D
placeboDIETARY_SUPPLEMENT

5 drops once daily for 12 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

  • older than 18 years of age
  • diagnosis of CF by sweat testing/genetics
  • vitamin D deficiency defined as a serum 25OHD level \< 75 nmol/L
  • on stable baseline vitamin D supplementation for at least 2 months. Standard vitamin D supplementation (cholecalciferol) in CF includes 800 IU daily for individuals with pancreatic insufficiency and 400 IU daily for those with pancreatic sufficiency

You may not qualify if:

  • Individuals with known hypercalcemia or renal stones
  • psychiatric history
  • use of tanning beds/travel to sunny location within the last 2 months
  • lung transplantation
  • pregnancy or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Cystic FibrosisVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Anne Stephenson, Dr.

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 29, 2008

Study Start

December 1, 2008

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

November 21, 2014

Record last verified: 2011-07

Locations

CA(1)