NCT01992263

Brief Summary

The goal of this study is to understand the effects of vitamin D supplementation on immunological outcomes among patients with tuberculosis.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
2 countries

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

November 1, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
7.5 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

November 1, 2013

Last Update Submit

September 8, 2020

Conditions

TuberculosisVitamin DImmunity

Keywords

tuberculosisvitamin Dimmunity

Outcome Measures

Primary Outcomes (3)

  • Immune function

    Immune responses will be assessed by the superoxide bursts and proteolytic capacities of macrophages and monocytes. Activity indexes will be assessed by comparing mean substrate and calibration fluorescence.

    One year

  • Cell-mediated immunological markers

    T cells

    One year

  • Vitamin D status

    Serum 25(OH)D concentrations

    One year

Secondary Outcomes (2)

  • TB treatment outcomes

    One year

  • HIV disease progression

    One year

Study Arms (4)

Vitamin D (600 IU)

EXPERIMENTAL
Dietary Supplement: Vitamin D (600 IU)

Vitamin D (2000 IU)

EXPERIMENTAL
Dietary Supplement: Vitamin D (2000 IU)

Vitamin D (4000 IU)

EXPERIMENTAL
Dietary Supplement: Vitamin D (4000 IU)

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Vitamin D (600 IU)DIETARY_SUPPLEMENT

Daily oral dose for 12 months

Vitamin D (600 IU)
Vitamin D (2000 IU)DIETARY_SUPPLEMENT

Daily oral dose for 12 months

Vitamin D (2000 IU)
Vitamin D (4000 IU)DIETARY_SUPPLEMENT

Daily oral dose for 12 months

Vitamin D (4000 IU)
PlaceboOTHER

Daily oral dose for 12 months

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Active TB diagnosis by GeneXpert
  • HIV infection status (according to AMC HIV clinic medical records of enzyme-linked immunosorbent assay \[ELISA\] results)

You may not qualify if:

  • Children (\<18 years of age)
  • years of age
  • Pregnant at baseline
  • Other severe complications or illnesses requiring hospitalization
  • Received TB treatment for greater than 4 weeks in the past 5 years
  • Refused to participate
  • Residing in a geographic location \> 1 hour from AMC (by public transit)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cornell University

Ithaca, New York, 14853, United States

Location

Arogyavaram Medical Centre (AMC)

Madanapalle, India

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Saurabh Mehta, MBBS, ScD

    Cornell University (U.S.)

    PRINCIPAL INVESTIGATOR

  • Wesley Bonam, BSc, MBBS, FAIMS, MRSH

    Arogyavaram Medical Centre (India)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saurabh Mehta, MBBS, ScD

CONTACT

607-255-2640smehta@cornell.edu

Elaine Yu, MPH

CONTACT

714-478-8599eay27@cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 25, 2013

Study Start

June 1, 2021

Primary Completion

September 1, 2022

Study Completion

February 1, 2023

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

IN(1)US(1)