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Effects of Vitamin D Supplementation in Obesity

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ClinicalTrials.gov Identifier: NCT01037140
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Vitamin D Deficiency Obesity Drug: Cholecalciferol Drug: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.
Study Start Date : January 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : July 2012

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Effect on circulating inflammatory markers [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. change in fat distribution [ Time Frame: 6 months ]
  2. change in insulin sensitivity [ Time Frame: 6 months ]
  3. change in bone mineral density [ Time Frame: 6 months ]
  4. change in quality of life [ Time Frame: 6 months ]
  5. change in depression score [ Time Frame: 6 months ]
  6. change in muscle function [ Time Frame: 6 months ]
  7. change in fat- and muscle metabolism [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037140


Locations
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Denmark
Dept. of Endocrinology and Metabolism, Aarhus University Hospital
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Louise Wamberg, Dr. Aarhus University Hospital
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01037140     History of Changes
Other Study ID Numbers: 2008-005581-31
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

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