NCT02750293

Brief Summary

Six-hundred subjects with vitamin D deficiency will be randomized to vitamin D 3000 IU per day versus placebo for 4 months, with effects on cardiovascular risk factors as main endpoint

Trial Health

87
On Track

Trial Health Score

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

Enrollment
411

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

2.2 years

First QC Date

April 12, 2016

Last Update Submit

October 24, 2017

Conditions

Vitamin D Deficiency

Keywords

vitamin Dblood pressureserum lipidsglucose metabolismmuscle functionarterial stiffnessdepressionpsoriasissleepbone density

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in systolic and diastolic blood pressure

    4 months

Secondary Outcomes (32)

  • Change from baseline in hand-grip, quadriceps and biceps muscle strength measured by hand held dynamometry .

    4 months

  • Change from baseline in score on Becks Depression Inventory

    4 months

  • Change from baseline in cognitive function evaluated with The Twelve Word Memory Test

    4 months

  • Change from baseline in cognitive function evaluated with The Digit Symbol Coding Test

    4 months

  • Change from baseline in cognitive function evaluated with The Tapping Test

    4 months

  • +27 more secondary outcomes

Study Arms (2)

cholecalciferol

ACTIVE COMPARATOR

vitamin D (as a 20 000 IU capsule) will be given once a week for 4 months

Drug: Cholecalciferol

placebo

PLACEBO COMPARATOR

placebo capsules (identical looking to the vitamin D capsules) will be given once a week for 4 months

Drug: Placebo

Interventions

CholecalciferolDRUG

Vitamin D preparation

Also known as: Dekristol
cholecalciferol
PlaceboDRUG

placebo

placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participated in The 7th survey in The Tromsø study
  • vitamin D deficiency

You may not qualify if:

  • primary hyperparathyroidism
  • granulomatous disease
  • reduced kidney function
  • systolic blood pressure \> 174 mmHg
  • diastolic blood pressure \> 104 mmHg
  • diabetes
  • renal stones last 5 years
  • use of solarium on regular basis
  • planned holidays in tropical areas
  • clinical depression
  • clinical signs of vitamin D deficiency (muscle weakness)
  • use of vitamin D supplements
  • serious illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

Related Publications (1)

  • Jorde R, Kubiak J, Svartberg J, Fuskevag OM, Figenschau Y, Martinaityte I, Grimnes G. Vitamin D supplementation has no effect on cognitive performance after four months in mid-aged and older subjects. J Neurol Sci. 2019 Jan 15;396:165-171. doi: 10.1016/j.jns.2018.11.020. Epub 2018 Nov 17.

    PMID: 30472553DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyDepressionPsoriasis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesBehavioral SymptomsBehaviorSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • rolf Jorde, Professor

    University of Tromso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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
Professor

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 25, 2016

Study Start

June 1, 2015

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

not planned

Locations

NO(1)