NCT00306410

Brief Summary

The purpose of this study is to determine the effect of normalization of vitamin D levels on bone density, immune and adipocyte function in HIV1-seropositive patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

March 22, 2006

Last Update Submit

February 28, 2007

Conditions

Vitamin D DeficiencyHIV Infections

Keywords

Vitamin D deficiencyHIV/AIDSHAARTT-Lymphocytes, Regulatoryinsulin resistancebone density

Outcome Measures

Primary Outcomes (1)

  • normalization of vitamin D levels at 12 weeks

Interventions

colecalciferolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 jr
  • able to give informed consent
  • HIV seropositive diagnosed with standard techniques
  • Hypovitaminoses D

You may not qualify if:

  • Hypercalcemia: calcium levels \>2.60 mmol/L
  • Renal disorders: serum creatinine \>2 times Upper limit of normal (ULN) (110 mmol/l)
  • Liver disorders; elevation of ASAT or ALAT \>5 x ULN. The ULNs are 40 IU/L and 45 IU/L for ASAT and ALAT, respectively.
  • Pregnancy
  • Drug or alcohol abuse
  • Non compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, P.O. BOX 9101, Netherlands

RECRUITING

Related Publications (5)

  • Madeddu G, Spanu A, Solinas P, Calia GM, Lovigu C, Chessa F, Mannazzu M, Falchi A, Mura MS, Madeddu G. Bone mass loss and vitamin D metabolism impairment in HIV patients receiving highly active antiretroviral therapy. Q J Nucl Med Mol Imaging. 2004 Mar;48(1):39-48.

    PMID: 15195003BACKGROUND

  • Haug CJ, Aukrust P, Haug E, Morkrid L, Muller F, Froland SS. Severe deficiency of 1,25-dihydroxyvitamin D3 in human immunodeficiency virus infection: association with immunological hyperactivity and only minor changes in calcium homeostasis. J Clin Endocrinol Metab. 1998 Nov;83(11):3832-8. doi: 10.1210/jcem.83.11.5270.

    PMID: 9814454BACKGROUND

  • Cozzolino M, Vidal M, Arcidiacono MV, Tebas P, Yarasheski KE, Dusso AS. HIV-protease inhibitors impair vitamin D bioactivation to 1,25-dihydroxyvitamin D. AIDS. 2003 Mar 7;17(4):513-20. doi: 10.1097/00002030-200303070-00006.

    PMID: 12598771BACKGROUND

  • Mondy K, Powderly WG, Claxton SA, Yarasheski KH, Royal M, Stoneman JS, Hoffmann ME, Tebas P. Alendronate, vitamin D, and calcium for the treatment of osteopenia/osteoporosis associated with HIV infection. J Acquir Immune Defic Syndr. 2005 Apr 1;38(4):426-31. doi: 10.1097/01.qai.0000145352.04440.1e.

    PMID: 15764959BACKGROUND

  • Holick MF. Vitamin D: important for prevention of osteoporosis, cardiovascular heart disease, type 1 diabetes, autoimmune diseases, and some cancers. South Med J. 2005 Oct;98(10):1024-7. doi: 10.1097/01.SMJ.0000140865.32054.DB.

    PMID: 16295817BACKGROUND

MeSH Terms

Conditions

Vitamin D DeficiencyHIV InfectionsAcquired Immunodeficiency SyndromeInsulin Resistance

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • André JAM van der Ven, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

André JA van der Ven, MD, PhD

CONTACT

+0031243618819a.vanderven@aig.umcn.nl

Carolien JP van den Bout-van den Beukel, MSc

CONTACT

+0031243618819c.vandenbeukel@aig.umcn.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2006

First Posted

March 23, 2006

Study Start

January 1, 2006

Study Completion

July 1, 2007

Last Updated

March 1, 2007

Record last verified: 2007-02

Locations

NL(1)