Study of Vitamin D Supplementation to Male HIV Sero-positive Patients - Full Text View

Sponsor:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00990678

Purpose

The investigators want to investigate if HIV sero-positive males benefit from vitamin D supplementation. The study runs in 16 weeks and the participants are treated with one of three placebo controlled regimes (tablets):

Calcium
Calcium and 25-hydroxy-vitamin D
Calcium and 25-hydroxy-vitamin D and 1,25-dihydroxyvitamin D

The endpoints are:

Serum vitamin D
Parathyroid hormone
ionized calcium
T-lymphocyte fractions (naïve, mature, Tregs)
Osteocalcin (bone metabolism)

Condition	Intervention
HIV Seropositive	Drug: Rocaltrol Drug: Vitamin D Drug: Calcium

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	Study of Vitamin D Supplementation to Male HIV Sero-positive Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS Calcium Dietary Supplements

Drug Information available for: Calcitriol Calcium gluconate Vitamin D

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

serum-vitamin D metabolites [ Time Frame: week 0 ] [ Designated as safety issue: Yes ]
serum-vitamin D metabolites [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
serum-vitamin D metabolites [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
serum-vitamin D metabolites [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
serum-vitamin D metabolites [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
serum-vitamin D metabolites [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 0 ] [ Designated as safety issue: Yes ]
T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	April 2008
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
"Strong vitamin D": Experimental Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily	Drug: Rocaltrol tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily Drug: Vitamin D tablets, vitamin D3, 30 microgram daily Drug: Calcium tablets, 400 mg calcium, 3 times daily
Vitamin D: Active Comparator calcium 400 mg + 10 microgram Vitamin D3, 3 times daily	Drug: Vitamin D tablets, vitamin D3, 30 microgram daily Drug: Calcium tablets, 400 mg calcium, 3 times daily
Calcium: Placebo Comparator Tablet Calcium 400 mg x 3 daily	Drug: Calcium tablets, 400 mg calcium, 3 times daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

male
HIV-positive
at least 18 years old
receiving HiglyActiveAntiRetroviral Therapy (HAART)

Exclusion Criteria:

hypercalcemia
tuberculosis
osteoporosis or other bone disease
cancer with bone metastasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990678

Contacts

Contact: Ulrich C Bang, M.D.	+4536322124	ulrichbangbang@gmail.com
Contact: Jens-Erik B Jensen, ph.d.	+4536323632	jebj@dadlnet.dk

Locations

Denmark
Dept. of endocrinology, Hvidovre Hospital	Recruiting
Copenhagen, Denmark, 2450
Contact: Ulrich C Bang, M.D. +4536322124 ulrichbangbang@gmail.com
Contact: Jens-Erik B Jensen, ph.d., M.D. +4536323632 jebj@dadlnet.dk

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

Principal Investigator:

Ulrich C Bang, M.D.

Dept. of Endocrinology, Hvidovre Hospital

More Information

No publications provided

Responsible Party:	Hvidovre Hospital, Dept. of Endocrinology ( Ulrich Bang, M.D., ph.d. student )
Study ID Numbers:	HH-JEBJ-HIVstudy, EudraCT 2006-005039-40, Danish Health 2612-3303
Study First Received:	October 6, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00990678 History of Changes
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:

HIV-1
humans
vitamin D
1-hydroxy-vitamin D

Rocaltrol
calcium
complementary therapies

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Calcium Channel Agonists
Ergocalciferols
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

Calcitriol
Membrane Transport Modulators
Vitamin D
Therapeutic Uses
Vitamins
Vasoconstrictor Agents
Micronutrients

ClinicalTrials.gov processed this record on November 30, 2009