- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02599675
Vitamin D Supplementation and Muscle Characteristics in Trained Subjects
Effects of 12 Weeks of Vitamin D Supplementation on Muscle Characteristics in Trained Subjects
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Lillehammer, Norwegen
- Lillehammer University College
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Vitamin D3
Vitamin D3 capsules for 12 weeks (2000 IU daily, equivalent to 50 ug)
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Vitamin D3 in Olivenöl gelöst, verkapselt
Andere Namen:
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Placebo-Komparator: Placebo
Placebo capsules for 12 weeks (the number of daily capsules will match that of the vitamin D-group)
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Olivenöl, eingekapselt
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Lower body maximal dynamic strength
Zeitfenster: wk 0, wk12
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Changes in the ability of lower body muscles to exert maximal force during a dynamic movement
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wk 0, wk12
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Muscle fiber composition
Zeitfenster: wk0, wk12
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Changes of the muscle fiber composition of musculus vastus lateralis in a 2X to 2A direction, measured using mRNA profiling
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wk0, wk12
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Gene expression in muscle
Zeitfenster: wk0, wk12
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Changes in RNA abundances in musculus vastus lateralis, measured at the level of single genes
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wk0, wk12
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Vitamin D in blood
Zeitfenster: wk0, wk12
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Changes in levels of 25(OH)D in blood
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wk0, wk12
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Steroid hormones in blood
Zeitfenster: wk0, wk12
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Changes in levels of steroid hormones in blood
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wk0, wk12
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Muscular endurance
Zeitfenster: wk0, wk12
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Changes in the ability of muscles to perform repeated dynamic contractions at submaximal loads (50% of 1 repetition maximum)
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wk0, wk12
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Upper body maximal dynamic strength
Zeitfenster: wk0, wk12
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Changes in the ability of upper body muscles to exert maximal force during dynamic movements
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wk0, wk12
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Training diary
Zeitfenster: From 1 month prior to study to post test (w12)
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Diary that includes information on type of training, duration and intensity performed
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From 1 month prior to study to post test (w12)
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Vitamin D-intake diary
Zeitfenster: From 1 month prior to study to post test (w12)
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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
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From 1 month prior to study to post test (w12)
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Sun exposure diary
Zeitfenster: From 1 month prior to study to post test (w12)
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Diary that includes information on exposure to solarium or sun in countries south of Norway
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From 1 month prior to study to post test (w12)
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Håvard Nygaard, MSc, Inland Norway University of Applied Sciences
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Trainsome 2015#006
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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