NCT00243256

Brief Summary

The purpose of the study is to evaluate if supplementation with vitamin D in doses of 20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as compared to placebo during 1 year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Nov 2005

Typical duration for phase_2 obesity

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

First Submitted

Initial submission to the registry

October 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 14, 2008

Status Verified

May 1, 2008

First QC Date

October 20, 2005

Last Update Submit

May 8, 2008

Conditions

Obesity

Outcome Measures

Primary Outcomes (7)

  • Body Weight

  • Body composition

  • Measures of calcium metabolism

  • Insulin sensitivity

  • Muscle strength

  • Depression score

  • Blood pressure

Interventions

CholecalciferolDRUG

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 30 - 40
  • serum calcium \< 2.55 mmol/L

You may not qualify if:

  • serious diseases
  • reduced kidney function
  • renal stone disease
  • using psychopharmaca
  • using drugs for weight reduction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Unit, University Hospital of North Norway

Tromsø, 9038, Norway

Location

Related Publications (1)

  • Jorde R, Sneve M, Torjesen PA, Figenschau Y, Hansen JB, Grimnes G. No significant effect on bone mineral density by high doses of vitamin D3 given to overweight subjects for one year. Nutr J. 2010 Jan 7;9:1. doi: 10.1186/1475-2891-9-1.

    PMID: 20056003DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Rolf Jorde, Professor

    University of Tromsø, Tromsø, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2005

First Posted

October 21, 2005

Study Start

November 1, 2005

Study Completion

December 1, 2007

Last Updated

May 14, 2008

Record last verified: 2008-05

Locations

NO(1)