Effects of Vitamin D Supplementation in Obesity

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01037140 History of Changes
Other Study ID Numbers:	2008-005581-31
First Posted:	December 21, 2009
Last Update Posted:	August 2, 2012
Last Verified:	August 2012

Additional relevant MeSH terms:

Obesity; Vitamin D Deficiency; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms; Avitaminosis; Deficiency Diseases	Malnutrition; Vitamins; Vitamin D; Ergocalciferols; Cholecalciferol; Micronutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents