NCT02186106

Brief Summary

Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our objective was to determine how to calculate the quantity of cholecalciferol needed for supplementation by single algorithm, usable on a patient-to-patient basis. We've conducted two studies. Study 1 was done retroactively and included 88 patients treated for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and aimed to test the validity of an algorithm based on data from study 1, which included patient BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

1.4 years

First QC Date

July 3, 2014

Last Update Submit

July 7, 2014

Conditions

Deficiency, Vitamin DObesity

Outcome Measures

Primary Outcomes (1)

  • Change in baseline value of [25-OH-vitamin-D]

    1 week, 3 weeks and 3 months

Study Arms (2)

Loading dose substitution

EXPERIMENTAL

Substituted with a highdose of cholecalciferol at study start

Drug: Cholecalciferol

Historic controls

NO INTERVENTION

Control subjects from journal archive

Interventions

CholecalciferolDRUG
Also known as: Dekristol capsules of 20.000 IU pr. capsule
Loading dose substitution

Eligibility Criteria

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

You may qualify if:

  • severe hypovitaminosis D (25OH-vit.D \<25 nmol/L)

You may not qualify if:

  • Malabsorption
  • Renal disease
  • Other treatment with vitamin D related products
  • Patients with a recent travel history with suspected increased sun exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin D DeficiencyObesity

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 10, 2014

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

July 10, 2014

Record last verified: 2014-07