- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01475890
Vitamin D Supplementation in HIV
Safe and Effective Vitamin D Supplementation in HIV
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy using clinically important outcomes, and this will overcome the critical barrier for use of vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit D supplementation may prove to be an effective and feasible treatment for symptoms and prevention of side effects for people of all ages living with HIV/AIDS in the US and around the world.
The study is a 12-month randomized, double blind, placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on evidence from the Vit D Dose Finding Study-IRB 09-007332 in 58 subjects with both Perinatally Acquired (PA) and Behaviorally Acquired (BA) HIV/AIDS to assess the long-term safety in terms of serum calcium and 25OHD concentrations, and efficacy in terms of the effect of vit D supplementation on 25OHD, cathelicidin, growth (pre- and peripubertal participants), body composition, bone, muscle, immune and inflammatory status and HIV/AIDS disease severity and progression.
Primary Hypotheses:
H1: Vit D supplementation is safe and does not result in an increased incidence of elevated serum calcium (above age-specific range) associated with elevated serum 25OHD (>160 ng/mL) in treated subjects compared with the subjects receiving placebo.
H2: Vit D supplementation is significantly associated with both increased 25D and cathelicidin in treated subjects compared with subjects receiving placebo.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19104
- Children's Hospital of Philadelphia
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- HIV seropositive diagnosed with standard techniques
- Age for PA Group: 5.0 to 24.9 y
- Age for BA Group: 15.0 to 24.9 y
- In usual state of good health (no hospitalizations, emergency room or unscheduled acute illness visits for 2 weeks prior to enrollment)
- Subject and/or family commitment to the 12-month study
Exclusion Criteria:
- Other chronic health conditions that may affect growth, dietary intake, and/or nutritional status
- Pregnancy
- Participation in another HIV intervention study with impact on 25D serum concentrations
- Use of vit D3 supplementation for the purpose of treating vit D deficiency
- Use of vit D3 supplementation not part of a prescribed treatment plan for vit D deficiency (subjects willing to discontinue supplementation will become eligible after a minimum of a 2 month washout period)
- Non-English Speaking
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 7000IU/day
29 subjects will be randomized to receive 7000IU/day of vitamin D3.
|
7000IU per day of vitamin D3 for 12 months.
|
Placebo-jämförare: Placebo
29 subjects will be randomized to receive placebo.
|
Once a day for 12 months.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Vitamin D Supplementation Safety
Tidsram: 12 months
|
elevated serum calcium (above age-specific range) associated with elevated serum 25D (>160 ng/mL)
|
12 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Virginia A Stallings, MD, Children's Hospital of Philadelphia
Publikationer och användbara länkar
Allmänna publikationer
- Rovner AJ, Stallings VA, Rutstein R, Schall JI, Leonard MB, Zemel BS. Effect of high-dose cholecalciferol (vitamin D3) on bone and body composition in children and young adults with HIV infection: a randomized, double-blind, placebo-controlled trial. Osteoporos Int. 2017 Jan;28(1):201-209. doi: 10.1007/s00198-016-3826-x. Epub 2016 Nov 11.
- Brown JC, Schall JI, Rutstein RM, Leonard MB, Zemel BS, Stallings VA. The impact of vitamin D3 supplementation on muscle function among HIV-infected children and young adults: a randomized controlled trial. J Musculoskelet Neuronal Interact. 2015 Jun;15(2):145-53.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Sexuellt överförbara sjukdomar, virala
- Sexuellt överförbara sjukdomar
- Lentivirusinfektioner
- Retroviridae-infektioner
- Immunologiska bristsyndrom
- Immunsystemets sjukdomar
- Långsamma virussjukdomar
- HIV-infektioner
- Förvärvat immunbristsyndrom
- Läkemedels fysiologiska effekter
- Mikronäringsämnen
- Vitaminer
- Bendensitetsbevarande medel
- Kalciumreglerande hormoner och medel
- Vitamin D
- Kolekalciferol
Andra studie-ID-nummer
- 11-008093
- 5R01AT005531-02 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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-
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