- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01037140
Effects of Vitamin D Supplementation in Obesity
Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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-
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Aarhus, Danmark
- Dept. of Endocrinology and Metabolism, Aarhus University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: placebo
|
oral placebo tablets similar to active comparator
|
|
Aktiv komparator: cholecalciferol
|
oral cholecalciferol tablets of 175 micrograms daily for 6 months
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Effect on circulating inflammatory markers
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
change in fat distribution
Tidsramme: 6 months
|
6 months
|
|
change in insulin sensitivity
Tidsramme: 6 months
|
6 months
|
|
change in bone mineral density
Tidsramme: 6 months
|
6 months
|
|
change in quality of life
Tidsramme: 6 months
|
6 months
|
|
change in depression score
Tidsramme: 6 months
|
6 months
|
|
change in muscle function
Tidsramme: 6 months
|
6 months
|
|
change in fat- and muscle metabolism
Tidsramme: 6 months
|
6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Louise Wamberg, Dr., Aarhus University Hospital
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2008-005581-31
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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