Effects of Vitamin D Supplementation in Obesity
Primary Purpose
Vitamin D Deficiency, Obesity
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Cholecalciferol
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
Eligibility 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
Sites / Locations
- Dept. of Endocrinology and Metabolism, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
cholecalciferol
placebo
Arm Description
Outcomes
Primary Outcome Measures
Effect on circulating inflammatory markers
Secondary Outcome Measures
change in fat distribution
change in insulin sensitivity
change in bone mineral density
change in quality of life
change in depression score
change in muscle function
change in fat- and muscle metabolism
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01037140
Brief Title
Effects of Vitamin D Supplementation in Obesity
Official Title
Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cholecalciferol
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
vitamin D
Intervention Description
oral cholecalciferol tablets of 175 micrograms daily for 6 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral placebo tablets similar to active comparator
Primary Outcome Measure Information:
Title
Effect on circulating inflammatory markers
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in fat distribution
Time Frame
6 months
Title
change in insulin sensitivity
Time Frame
6 months
Title
change in bone mineral density
Time Frame
6 months
Title
change in quality of life
Time Frame
6 months
Title
change in depression score
Time Frame
6 months
Title
change in muscle function
Time Frame
6 months
Title
change in fat- and muscle metabolism
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Wamberg, Dr.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Endocrinology and Metabolism, Aarhus University Hospital
City
Aarhus
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
35018442
Citation
Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.
Results Reference
derived
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Effects of Vitamin D Supplementation in Obesity
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