NCT02595489 is a Phase 1 clinical trial of vitamin D3 in X-linked Adrenoleukodystrophy, sponsored by Stanford University.

Who is sponsoring NCT02595489?

NCT02595489 is sponsored by Stanford University.

What drugs are being tested in NCT02595489?

Interventions in NCT02595489: vitamin D3.

What condition does NCT02595489 study?

NCT02595489 studies X-linked Adrenoleukodystrophy.

Is NCT02595489 still recruiting?

NCT02595489 is currently completed. Last updated 9 June 2022.

Last reviewed 2022-06-09 · How we verify

NCT02595489

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 9 June 2022

What this trial tests

Phase 1 trial testing vitamin D3 in X-linked Adrenoleukodystrophy in 21 participants. Completed in 30 June 2020.

Timeline

21 November 2016

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Stanford University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	21
Start date	21 November 2016
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across United States

Drugs / interventions tested

vitamin D3 (cholecalciferol) — full drug profile →

Conditions studied

X-linked Adrenoleukodystrophy — all drugs for X-linked Adrenoleukodystrophy →

Sponsor

Stanford University

Who can join

Adults 18 Months to 25, male only, with X-linked Adrenoleukodystrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

A Phase 1 Study of Oral Vitamin D<sub>3</sub> in Boys and Young Men With X-Linked Adrenoleukodystrophy.
Van Haren KP, Cunanan K, Awani A, Gu M, et al · · 2023 · cited 7× · PMID 37090939 · DOI 10.1212/nxg.0000000000200061
Effect of vitamin D supplementation on cerebral blood flow in male patients with adrenoleukodystrophy.
Zhao MY, Dahlen A, Ramirez NJ, Moseley M, et al · · 2023 · cited 3× · PMID 36967233 · DOI 10.1002/jnr.25187
Decision Making in Adrenoleukodystrophy: When Is a Good Outcome Really a Good Outcome?
Van Haren K, Engelen M. · · 2017 · cited 3× · PMID 28418445 · DOI 10.1001/jamaneurol.2017.0095
A phase I study of oral vitamin D3 in boys with X-linked adrenoleukodystrophy
Van Haren K, Cunanan K, Awani A, Gu M, et al · · 2022 · DOI 10.1101/2021.12.28.21267861

Verify or expand the search:

Other trials of vitamin D3

Trials testing the same drug.

NCT06896669 — Effects of Vitamin D and Calcium on Hyperglycemia and Dyslipidemia in Patients Gestational Diabetes · NA · completed
NCT04331639 — High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy · recruiting
NCT04005612 — Effect of Vitamin d and Omega 3 on Osteocalcin · NA · completed
NCT05073029 — Open Label Randomized Clinical Study to Promote a Healthy Lifestyle in Medical Students · NA · completed
NCT03534674 — Vitamin D3 Supplementation for AlloHSCT-RCT · NA · unknown

Other recruiting trials for X-linked Adrenoleukodystrophy

Currently open trials in the same condition.

NCT03727555 — IT and IV Lentiviral Gene Therapy for X-ALD · NA · recruiting
NCT05939232 — Registry of X-linked Adrenoleukodystrophy · recruiting
NCT04675749 — Quality of Life in Women with X-linked Adrenoleukodystrophy · recruiting
NCT03047369 — The Myelin Disorders Biorepository Project · recruiting

Other Stanford University trials

Trials by the same sponsor.

NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
NCT04225949 — Patients Understanding of PROM Graphs · NA · withdrawn
NCT06273098 — School-Based Bladder Health Intervention · NA · withdrawn
NCT04652635 — Management of Nailbed Injuries · NA · withdrawn
NCT05443503 — Stanford Spine Keeper - Managing Your Low Back Pain · NA · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02595489 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stanford University
Last refreshed: 9 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02595489.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing