MedDataX Logo

Effects of Vitamin D Supplementation in Obesity

NCT ID: NCT01037140

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cholecalciferol

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

oral cholecalciferol tablets of 175 micrograms daily for 6 months

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral placebo tablets similar to active comparator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cholecalciferol

oral cholecalciferol tablets of 175 micrograms daily for 6 months

Intervention Type DRUG

placebo

oral placebo tablets similar to active comparator

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

vitamin D

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Louise Wamberg, Dr.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept. of Endocrinology and Metabolism, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35018442 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-005581-31

Identifier Type: -

Identifier Source: org_study_id