- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02954549
Vitamin D Supplementation in Warfighters
Genomics of Vitamin D Supplementation and Warfighter Nutritional Resilience
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Washington
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Tacoma, Washington, Forenede Stater, 98431
- Madigan Army Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- active duty service member, age 18 years or older, ability to read and understand English, not deploying in the next 15 months, and subjectively in good health.
Exclusion Criteria:
- family members, beneficiaries, or civilians, pregnant or currently breastfeeding females, anyone with chronic health problems (e.g. eating disorders, kidney disease, liver disease, intestinal malabsorption), any active duty SM taking >400 IU/day vitamin D supplementation and unwilling to discontinue this, current or healing stress fractures, taking medications for an endocrine disorder, such as synthroid, or those identified as having a high potential for interaction with vitamin D including anti-seizure medications, cyclosporine, and indinavir (Crixivan).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Healthy control group
Subjects in this arm have a normal serum level of 25(OH)D, >30 ng/mL.
Subjects submit to blood draws and biometric tests (DXA, body composition, BP) and questionnaires on 3 occasions.
They do not receive vitamin D3 supplementation.
|
As in Arms
Andre navne:
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Eksperimentel: Low dose supplementation group
Subjects in this group have been identified as having a level of 25(OH)D of < 30 ng/mL and are randomized to receive vitamin D3 supplementation of 2000 IU daily for 3 months.
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As in Arms
Andre navne:
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Eksperimentel: High dose supplementation group
Subjects in this group have been identified as having a level of 25(OH)D of <30 ng/mL and are randomized to receive vitamin D3 supplementation of 5000 IU daily for 3 months.
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As in Arms
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
25(OH)D
Tidsramme: 15 months
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Serum measure of 25(OH) at baseline, 3 months, and 15 months
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15 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Vitamin D gene expression
Tidsramme: 3 months
|
Gene expression analysis will be used to determine relationship between low and high dose vitamin D supplementation and 25(OH)D levels, blood pressure, bone density, and body fat
|
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mary S McCarthy, PhD, Madigan Army Medical Center
Publikationer og nyttige links
Generelle publikationer
- Fiscella K, Franks P. Vitamin D, race, and cardiovascular mortality: findings from a national US sample. Ann Fam Med. 2010 Jan-Feb;8(1):11-8. doi: 10.1370/afm.1035.
- Yanovich R, Friedman E, Milgrom R, Oberman B, Freedman L, Moran DS. Candidate gene analysis in israeli soldiers with stress fractures. J Sports Sci Med. 2012 Mar 1;11(1):147-55. eCollection 2012.
- Carlberg C. Genome-wide (over)view on the actions of vitamin D. Front Physiol. 2014 Apr 29;5:167. doi: 10.3389/fphys.2014.00167. eCollection 2014.
- Hossein-nezhad A, Spira A, Holick MF. Influence of vitamin D status and vitamin D3 supplementation on genome wide expression of white blood cells: a randomized double-blind clinical trial. PLoS One. 2013;8(3):e58725. doi: 10.1371/journal.pone.0058725. Epub 2013 Mar 20.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Metaboliske sygdomme
- Ernæringsforstyrrelser
- Muskuloskeletale sygdomme
- Avitaminose
- Fejlernæring
- Knoglesygdomme
- Knoglesygdomme, metaboliske
- Calciummetabolismeforstyrrelser
- D-vitamin mangel
- Rakitis
- Mangelsygdomme
- Lægemidlers fysiologiske virkninger
- Mikronæringsstoffer
- Vitaminer
- Knogletæthedsbevarende midler
- Calciumregulerende hormoner og midler
- D-vitamin
- Cholecalciferol
Andre undersøgelses-id-numre
- HU001-15-1-TS05
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Vitamin D Deficiency Disease
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University of UlsterNorthern Ireland Executive; HSC Public Health AgencyAfsluttetD-vitamin status | D-vitamin koncentrationDet Forenede Kongerige
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Hospices Civils de LyonAfsluttet
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Horopito LimitedAtlantia Food Clinical TrialsAfsluttet
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Federal University of Rio Grande do SulAfsluttet
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Factors Group of Nutritional Companies Inc.Afsluttet
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Mike O'Callaghan Military HospitalTrukket tilbageD-vitaminForenede Stater
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Rajavithi HospitalQueen Sirikit National Institute of Child HealthAfsluttet
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Universidade de Passo FundoUkendt
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University of CopenhagenAfsluttet
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Sheffield Children's NHS Foundation TrustAfsluttet
Kliniske forsøg med Vitamin D3
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Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Aktiv, ikke rekrutterende
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Medical University of South CarolinaThrasher Research FundAfsluttetD-vitamin mangel | GraviditetForenede Stater
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Aga Khan UniversityAfsluttet
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University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National... og andre samarbejdspartnereAfsluttetHIV-infektionForenede Stater, Puerto Rico
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Rutgers UniversityAfsluttet
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Brigham and Women's HospitalNational Center for Maternal and Child Health Research, Mongolia; Zuun...AfsluttetD-vitamin mangel | GraviditetMongoliet
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Aalborg UniversityAalborg University Hospital; CCBR Aalborg A/S, Aalborg, DenmarkAfsluttetMigræne ifølge International Headache Society (IHS) kriterier (ICHD-II)Danmark
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Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereAfsluttet
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National Institute of Allergy and Infectious Diseases...Autoimmunity Centers of ExcellenceAfsluttetSystemisk lupus erythematosusForenede Stater
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University of California, San FranciscoAfsluttetColitis ulcerosa (UC) | Crohns sygdom (CD)Forenede Stater