Vitamin D Dose Finding Study

NCT01092338 | Completed Phase 2 Results DMC

• 2 other identifiers: 09-007332R01AT005531
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; AIDS

Keywords

Human Immunodeficiency Virus; Acquired Immune Deficiency Syndrome; Vitamin D; HIV; Complementary therapies

Outcome Measures

Primary Outcomes (2)

• Safety

  Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (\>160ng/ml).

  12 weeks

• Efficacy of the Two Doses (4000 and 7000 IU/d)

  Daily D3 supplementation will result in 25D \>= to 32/ng/ml

  12 weeks

Study Arms (2)

4000IU

ACTIVE COMPARATOR

Subjects in this arm take a daily dose of 4000IU of Vitamin D3

Drug: Cholecalciferol (Vit D3)

7000IU

ACTIVE COMPARATOR

Subjects in this arm of the study take a daily dose of 7000IU of Vitamin D3

Drug: Cholecalciferol (Vit D3)

Interventions

Cholecalciferol (Vit D3) DRUG

To test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement (capsules or liquid) over a 3-month period in 44 children, adolescents and adults with HIV/AIDS.

Also known as: Carlson D Drops: The D Drop Company, Nutraceutical Life Sciences Vitamin D3 2000 IU capsules: Vitacost, NOW Foods 5000 IU softgels: Now Health Group, Inc.

4000IU; 7000IU

Eligibility Criteria

• Age: 5 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HIV seropositive diagnosed with standard techniques
• Age for perinatally-acquired HIV/AIDS Group (PA subjects): 5.0 to 24.9 y
• Age for non-perinatally-acquired HIV/AIDS Group (non-PA subjects): 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)
• Subject and/or family commitment to the 3-month study

You may not qualify if:

• 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 D supplementation (subjects willing to discontinue supplementation will become eligible after a 2-month washout period)
• Baseline elevated serum calcium concentration
• Non-English speaking

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Groleau V, Herold RA, Schall JI, Wagner JL, Dougherty KA, Zemel BS, Rutstein RM, Stallings VA. Blood lead concentration is not altered by high-dose vitamin D supplementation in children and young adults with HIV. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):316-9. doi: 10.1097/MPG.0b013e3182758c4a.

  PMID: 23059649 RESULT

• Dougherty KA, Schall JI, Zemel BS, Tuluc F, Hou X, Rutstein RM, Stallings VA. Safety and Efficacy of High-Dose Daily Vitamin D3 Supplementation in Children and Young Adults Infected With Human Immunodeficiency Virus. J Pediatric Infect Dis Soc. 2014 Dec;3(4):294-303. doi: 10.1093/jpids/piu012. Epub 2014 Mar 27.

  PMID: 26625449 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Virginia Stallings
• Organization: Children's Hospital of Philadephia

stallingsv@email.chop.edu

215-590-1664

Study Officials

• Virginia Stallings, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 24, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 18, 2013
• Results First Posted: September 18, 2013

Record last verified: 2013-08

Locations

US (1)