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Completed

NCT Number: NCT01037140

Effects of Vitamin D Supplementation in Obesity

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept. of Endocrinology and Metabolism, Aarhus University Hospital

Aarhus, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

oral cholecalciferol tablets of 175 micrograms daily for 6 months

Other names: vitamin D

Placebo

Drug

oral placebo tablets similar to active comparator

Primary outcomes

  1. Effect on circulating inflammatory markers

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Dec 21, 2009
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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