NCT01037140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

1.9 years

First QC Date

December 8, 2009

Last Update Submit

August 1, 2012

Conditions

Vitamin D DeficiencyObesity

Outcome Measures

Primary Outcomes (1)

  • Effect on circulating inflammatory markers

    6 months

Secondary Outcomes (7)

  • change in fat distribution

    6 months

  • change in insulin sensitivity

    6 months

  • change in bone mineral density

    6 months

  • change in quality of life

    6 months

  • change in depression score

    6 months

  • +2 more secondary outcomes

Study Arms (2)

cholecalciferol

ACTIVE COMPARATOR
Drug: Cholecalciferol

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

CholecalciferolDRUG

oral cholecalciferol tablets of 175 micrograms daily for 6 months

Also known as: vitamin D
cholecalciferol
placeboDRUG

oral placebo tablets similar to active comparator

placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy obese (BMI 30 - 45 kg/m2)
  • (OH) vitamin D \< 50 nmol/l

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Endocrinology and Metabolism, Aarhus University Hospital

Aarhus, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 35018442DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyObesity

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Louise Wamberg, Dr.

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 21, 2009

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

July 1, 2012

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

DK(1)