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A Pilot Study of Vitamin D in Boys With X-linked Adrenoleukodystrophy

NCT02595489 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-06-09

No results posted yet for this study

Summary

In this pilot study, the investigators will assess the safety of two high-dose regimens of oral vitamin D supplementation and measure the effects of vitamin D supplementation on markers of oxidative stress and inflammation in the blood and brain of study participants before, during, and after taking vitamin D supplements.

The goal of the study is to establish research measures (i.e. biomarkers) and an optimal dose for vitamin D supplementation in boys with the X-linked adrenoleukodystrophy (ALD) genotype.

Conditions

  • X-linked Adrenoleukodystrophy

Interventions

DIETARY_SUPPLEMENT

vitamin D3

Daily oral supplement provided by study investigators

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    collaborator OTHER

  • ALD Connect, Inc.

    collaborator INDUSTRY

  • Stanford University

    lead OTHER

Principal Investigators

  • Keith Van Haren, MD · Stanford University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Months
Max Age
25 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-21
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02595489 on ClinicalTrials.gov