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Completed

NCT Number: NCT00990678

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

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):

1. Calcium 2. Calcium and 25-hydroxy-vitamin D 3. 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)

Completed

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Key information

Conditions

HIV Seropositive Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of endocrinology, Hvidovre Hospital

Copenhagen, 2450, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocaltrol

Drug

tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily

Vitamin D

Drug

tablets, vitamin D3, 30 microgram daily

calcium

Drug

tablets, 400 mg calcium, 3 times daily

Primary outcomes

  1. serum-vitamin D metabolites

    Time frame: week 0

  2. serum-vitamin D metabolites

    Time frame: week 2

  3. serum-vitamin D metabolites

    Time frame: week 4

  4. serum-vitamin D metabolites

    Time frame: week 8

  5. serum-vitamin D metabolites

    Time frame: week 12

  6. serum-vitamin D metabolites

    Time frame: week 16

Secondary outcomes

  1. T-lymphocyte fractions Parathyroid hormone ionized calcium

    Time frame: week 0

  2. T-lymphocyte fractions Parathyroid hormone ionized calcium

    Time frame: week 2

  3. T-lymphocyte fractions Parathyroid hormone ionized calcium

    Time frame: week 4

  4. T-lymphocyte fractions Parathyroid hormone ionized calcium

    Time frame: week 8

  5. T-lymphocyte fractions Parathyroid hormone ionized calcium

    Time frame: week 12

  6. T-lymphocyte fractions Parathyroid hormone ionized calcium

    Time frame: week 16

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Oct 7, 2009
Registry last updated
Sep 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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