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Vitamin D Supplementation and Muscle Characteristics in Trained Subjects

7. september 2017 oppdatert av: Inland Norway University of Applied Sciences

Effects of 12 Weeks of Vitamin D Supplementation on Muscle Characteristics in Trained Subjects

This study evaluates the effect of vitamin D supplementation on outcomes muscle performance and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be allocated to ingest either vitamin D (35) or placebo (35) in a double-blinded fashion

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Vitamin D insufficiency compromises muscle functionality, leading to changes in muscle mass and strength, manifested at the cellular level. While this is increasingly recognized as a problem for individuals with vitamin D deficiency (typically 25(OH)D < 25 nmol/l), there is no general consensus for the remainder of the vitamin D-spectra. This lack of knowledge is probably linked to the variation in protocols of studies that have investigated the physiological role of vitamin D. These variations vary from aspects such as interventional vs observational studies to aspects related to subject characteristics such as age, health and training status. In this project, we will evaluate the effects of 12 weeks of vitamin D supplementation (2000 IU/day) on muscle performance and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be allocated to either a vitamin D (35) or a placebo group (35) in a double-blinded manner. They will be instructed to continue their ordinary modes and frequency of training.

We anticipate baseline vitamin D levels in blood (and hence changes in vitamin D obtained through supplementation), measured as 25(OH)D, to be a major determinant of the efficacy of the intervention. This means that we expect individuals with low baseline levels of 25(OH)D to display more pronounced changes in functional and biological outcome measures than those with high baseline values. Such a scenario could be related to an inability of our protocol to increase blood levels of 25(OH)D in individuals with higher physiological levels of vitamin D (which essentially means that ingestion of vitamin D3 is leveled out or exceeded by elimination of vitamin D derivatives). Alternatively, it may be related to inabilities of tissues to respond to the resulting elevation in vitamin D levels. To study the individual variation in vitamin D responses, data on both functional and biological variables will be divided into quartiles based on baseline 25(OH)D-levels, whereupon comparisons will be made between the low-end and high-end quartile. Individual variation will also be assessed using a mixed model approach.

Studietype

Intervensjonell

Registrering (Faktiske)

71

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Lillehammer, Norge
        • Lillehammer University College

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 40 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

- Individuals that have performed strength and / or endurance exercise training at least 3 X week for at least 6 months prior to the study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Vitamin D3
Vitamin D3 capsules for 12 weeks (2000 IU daily, equivalent to 50 ug)
Vitamin D3 oppløst i olivenolje, innkapslet
Andre navn:
  • kolekalsiferol
Placebo komparator: Placebo
Placebo capsules for 12 weeks (the number of daily capsules will match that of the vitamin D-group)
Olivenolje, innkapslet

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Lower body maximal dynamic strength
Tidsramme: wk 0, wk12
Changes in the ability of lower body muscles to exert maximal force during a dynamic movement
wk 0, wk12
Muscle fiber composition
Tidsramme: wk0, wk12
Changes of the muscle fiber composition of musculus vastus lateralis in a 2X to 2A direction, measured using mRNA profiling
wk0, wk12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gene expression in muscle
Tidsramme: wk0, wk12
Changes in RNA abundances in musculus vastus lateralis, measured at the level of single genes
wk0, wk12
Vitamin D in blood
Tidsramme: wk0, wk12
Changes in levels of 25(OH)D in blood
wk0, wk12
Steroid hormones in blood
Tidsramme: wk0, wk12
Changes in levels of steroid hormones in blood
wk0, wk12
Muscular endurance
Tidsramme: wk0, wk12
Changes in the ability of muscles to perform repeated dynamic contractions at submaximal loads (50% of 1 repetition maximum)
wk0, wk12
Upper body maximal dynamic strength
Tidsramme: wk0, wk12
Changes in the ability of upper body muscles to exert maximal force during dynamic movements
wk0, wk12

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Training diary
Tidsramme: From 1 month prior to study to post test (w12)
Diary that includes information on type of training, duration and intensity performed
From 1 month prior to study to post test (w12)
Vitamin D-intake diary
Tidsramme: From 1 month prior to study to post test (w12)
Diary withthat includes information on approximate intake of vitamin D from sources other than the study-specific supplement, including ingestion of fish, seafood and vitamin D-supplement
From 1 month prior to study to post test (w12)
Sun exposure diary
Tidsramme: From 1 month prior to study to post test (w12)
Diary that includes information on exposure to solarium or sun in countries south of Norway
From 1 month prior to study to post test (w12)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Håvard Nygaard, MSc, Inland Norway University of Applied Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2015

Primær fullføring (Faktiske)

28. februar 2017

Studiet fullført (Faktiske)

28. februar 2017

Datoer for studieregistrering

Først innsendt

5. november 2015

Først innsendt som oppfylte QC-kriteriene

5. november 2015

Først lagt ut (Anslag)

6. november 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. september 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. september 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

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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