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Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)

U

University of Tromso (UiT)

Status and phase

Completed
Phase 2

Conditions

Obesity

Treatments

Drug: Cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT00243256
CSEMDT-2005-2

Details and patient eligibility

About

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.

Full description

We will include 450 obese subjects that will be devided in 3 groups: 40.000IU cholecalciferol per week, 20.000 IU cholecalciferol per week, and placebo. All subjects will be given 500 mg calcium per day. There will be visits every tird month. In addition to weight reduction, we will also evaluate the calcium metabolism (blood test and urin samples), insulin sensitivity, muscle strenght, blood pressure and depression.

Enrollment

450 estimated patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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