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Effects of Vitamin D Supplementation in Obesity

Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01037140
Enrollment
55
Registered
2009-12-21
Start date
2010-01-31
Completion date
2012-07-31
Last updated
2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Vitamin D Deficiency

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.

Interventions

DRUGCholecalciferol

oral cholecalciferol tablets of 175 micrograms daily for 6 months

DRUGplacebo

oral placebo tablets similar to active comparator

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Effect on circulating inflammatory markers6 months

Secondary

MeasureTime frame
change in insulin sensitivity6 months
change in bone mineral density6 months
change in quality of life6 months
change in fat distribution6 months
change in muscle function6 months
change in fat- and muscle metabolism6 months
change in depression score6 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026