Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306410
Status:
UNKNOWN
Last Update Posted:
2007-03-01
First Post:
2006-03-22
Brief Title:
The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Vitamin D deficiency is common in especially black HIV-seropositive patients Vitamin D deficiency can be caused by lack of sunlight andor insufficient vitamin D intake via diet The HIV infection itself and antiretroviral therapy ART may also cause vitamin D deficiency ART interferes with cytochrome p450 activity and as such might affect vitamin D metabolism
Vitamin D has several important physiological functions such as 1 regulation of calcium and phosphate homeostasis 2 immunomodulatory properties and 3 effects on adipocyte differentiation Low vitamin D levels lead to decreased bone mineralization eventually resulting in rachitischildren or osteomalacia in adults In addition vitamin D deficiency leads to secondary hyperparathyroidism which leads to even more bone matrix demineralization In HIV infected persons the overall prevalence of osteopenia and osteoporoses is 14-84 and 0-45 respectively Vitamin D has been suggested to play a role in HIV-associated bone disorders The vitamin D status also affects the host defence in HIV patients a significantly lower CD4 cell count has been found in patients with 125OHvitamin D deficiency Furthermore the influence of vitamin D on adipocyte differentiation and the effect of HAART on vitamin D levels might be relevant for changes in fat distribution and the development of insulin resistance as is seen days after initiation of HAART
Vitamin D is metabolized in the body trough cytochrome P450 enzymes HAART might interact with vitamin D metabolism on basis of CYP3A4 which plays an important role in clearance of most antiretroviral agents and also showed to be a vitamin D 24 and 25-hydroxylase in vitro We hypothesize that PIs lead to lower 1a25OH2D3 by suppressing 1a- and 25-hydroxylase activity
The results of our pilot showed that 25OHD deficiency is common among HIV patients Seen the diversity of functions of vitamin D we hypothesize that its beneficial for the patients to have a normal vitamin D status Therefore supplementation of vitamin D is warranted
In this study we want to investigate if despite the complex interaction between HAART HIV and vitamin D metabolism supplementation of colecalciferol 2000 IU daily will lead to normalization of the vitamin D levels Furthermore we want to study the effects of normalization of vitamin D levels on bone mineral density immune and adipocyte function Therefore we will do a prospective randomized double-blind placebo-controlled vitamin D intervention study in vitamin D deficient HIV1-seropositive patients
Vitamin D has several important physiological functions such as 1 regulation of calcium and phosphate homeostasis 2 immunomodulatory properties and 3 effects on adipocyte differentiation Low vitamin D levels lead to decreased bone mineralization eventually resulting in rachitischildren or osteomalacia in adults In addition vitamin D deficiency leads to secondary hyperparathyroidism which leads to even more bone matrix demineralization In HIV infected persons the overall prevalence of osteopenia and osteoporoses is 14-84 and 0-45 respectively Vitamin D has been suggested to play a role in HIV-associated bone disorders The vitamin D status also affects the host defence in HIV patients a significantly lower CD4 cell count has been found in patients with 125OHvitamin D deficiency Furthermore the influence of vitamin D on adipocyte differentiation and the effect of HAART on vitamin D levels might be relevant for changes in fat distribution and the development of insulin resistance as is seen days after initiation of HAART
Vitamin D is metabolized in the body trough cytochrome P450 enzymes HAART might interact with vitamin D metabolism on basis of CYP3A4 which plays an important role in clearance of most antiretroviral agents and also showed to be a vitamin D 24 and 25-hydroxylase in vitro We hypothesize that PIs lead to lower 1a25OH2D3 by suppressing 1a- and 25-hydroxylase activity
The results of our pilot showed that 25OHD deficiency is common among HIV patients Seen the diversity of functions of vitamin D we hypothesize that its beneficial for the patients to have a normal vitamin D status Therefore supplementation of vitamin D is warranted
In this study we want to investigate if despite the complex interaction between HAART HIV and vitamin D metabolism supplementation of colecalciferol 2000 IU daily will lead to normalization of the vitamin D levels Furthermore we want to study the effects of normalization of vitamin D levels on bone mineral density immune and adipocyte function Therefore we will do a prospective randomized double-blind placebo-controlled vitamin D intervention study in vitamin D deficient HIV1-seropositive patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None