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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
 Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015