NCT01475890

Brief Summary

The purpose of this study is to evaluate safety and efficacy of vitamin D supplementation in children, adolescents and young adults with Human Immunodeficiency Virus and acquired immunodeficiency syndrome (HIV/AIDS). The study is a 12-month randomized, double blind, placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on evidence from the Vit D Dose Finding Study-IRB 09-007332.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

September 13, 2011

Last Update Submit

March 15, 2017

Conditions

HIV-infection/Aids

Keywords

HIV/AIDSNutrition

Outcome Measures

Primary Outcomes (1)

  • Vitamin D Supplementation Safety

    elevated serum calcium (above age-specific range) associated with elevated serum 25D (\>160 ng/mL)

    12 months

Study Arms (2)

7000IU/day

ACTIVE COMPARATOR

29 subjects will be randomized to receive 7000IU/day of vitamin D3.

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

29 subjects will be randomized to receive placebo.

Dietary Supplement: Placebo

Interventions

Vitamin D3DIETARY_SUPPLEMENT

7000IU per day of vitamin D3 for 12 months.

7000IU/day
PlaceboDIETARY_SUPPLEMENT

Once a day for 12 months.

Placebo

Eligibility Criteria

Age5 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HIV seropositive diagnosed with standard techniques
  • Age for PA Group: 5.0 to 24.9 y
  • Age for BA Group: 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 to enrollment)
  • Subject and/or family commitment to the 12-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 D3 supplementation for the purpose of treating vit D deficiency
  • Use of vit D3 supplementation not part of a prescribed treatment plan for vit D deficiency (subjects willing to discontinue supplementation will become eligible after a minimum of a 2 month washout period)
  • Non-English Speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Rovner AJ, Stallings VA, Rutstein R, Schall JI, Leonard MB, Zemel BS. Effect of high-dose cholecalciferol (vitamin D3) on bone and body composition in children and young adults with HIV infection: a randomized, double-blind, placebo-controlled trial. Osteoporos Int. 2017 Jan;28(1):201-209. doi: 10.1007/s00198-016-3826-x. Epub 2016 Nov 11.

    PMID: 27837268DERIVED

  • Brown JC, Schall JI, Rutstein RM, Leonard MB, Zemel BS, Stallings VA. The impact of vitamin D3 supplementation on muscle function among HIV-infected children and young adults: a randomized controlled trial. J Musculoskelet Neuronal Interact. 2015 Jun;15(2):145-53.

    PMID: 26032206DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Virginia A Stallings, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

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

September 13, 2011

First Posted

November 22, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2013

Study Completion

February 1, 2017

Last Updated

March 17, 2017

Record last verified: 2017-03

Locations

US(1)