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Effects of Vitamin D Supplementation in Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01037140
First received: December 8, 2009
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

Obesity is an increasing health problem with numerous metabolic complications. Vitamin D deficiency is common in obesity, and in epidemiological studies vitamin D deficiency has been linked to metabolic complications, such as type 2 diabetes, insulin resistance and cardiovascular disease, as well as myopathy, osteoporosis and depression. In obesity, a low grade inflammation is present in the fat tissue, thereby releasing inflammatory molecules to the blood stream. In cell line studies as well as small clinical studies vitamin D has been shown to have the ability to reduce inflammation and cell growth.

In the present study the investigators wish to investigate the effect of vitamin D on fat-, muscle and bone metabolism. 30 healthy obese subjects will be treated with cholecalciferol 175 micrograms daily for 6 months and will be compared with 30 healthy obese subjects treated with placebo.

The investigators hypothesize that restoring vitamin D levels in vitamin D deficient obese subject will reduce inflammation and thereby reduce obesity-related complications.

The effect will be evaluated as follows:

  • Levels of circulating inflammatory markers will be examined in blood samples collected prior to and after treatment.
  • Effects on fat- and muscle metabolism will be evaluated in fat- and muscle samples taken before and after treatment.
  • Effects on fat distribution will be evaluated by MRI scan before and after treatment.
  • Effects on insulin sensitivity will be evaluated by hyperinsulinaemic euglycaemic clamp performed on a subgroup of subjects with impaired fasting glucose.
  • Effects on bone marrow density will be evaluated by DEXA scans before and after treatment.
  • Effects on quality of life and depression score will be evaluated by questionnaires used before and after treatment.

Condition Intervention Phase
Vitamin D Deficiency
Obesity
 Drug: Cholecalciferol
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Effect on circulating inflammatory markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in fat distribution [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change in insulin sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change in bone mineral density [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change in quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change in depression score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change in muscle function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change in fat- and muscle metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cholecalciferol Drug: Cholecalciferol
oral cholecalciferol tablets of 175 micrograms daily for 6 months
Other Name: vitamin D
Placebo Comparator: placebo Drug: placebo
oral placebo tablets similar to active comparator

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy obese (BMI 30 - 45 kg/m2)
  • 25(OH) vitamin D < 50 nmol/l

Exclusion Criteria:

  • Diabetes,
  • Pregnancy or non-safe contraception,
  • Vitamin D treatment within 3 months,
  • Hypercalcaemia, renal failure,
  • Liver failure, non eligibility for MRI-scan,
  • Severe osteomalacia,
  • Allergy towards study drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037140

Locations
Denmark
Dept. of Endocrinology and Metabolism, Aarhus University Hospital
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Louise Wamberg, Dr. Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01037140     History of Changes
Other Study ID Numbers: 2008-005581-31
Study First Received: December 8, 2009
Last Updated: August 1, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Obesity
Vitamin D Deficiency
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
 Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 17, 2013