Trial · NCT01525875

Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE)

NCT01525875, Phase 2, Completed, Mark Lebwohl; results first posted 2019-04-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE). Trials, record NCT01525875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01525875

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE)
NCT number: NCT01525875
Status: Completed
Phases: Phase 2
Enrollment: 44 participants, actual
Lead sponsor: Mark Lebwohl
Conditions: Pseudoxanthoma Elasticum
Interventions: Magnesium Oxide, Placebo
First posted: 2012-02-03
Last updated: 2021-03-10
Results first posted: 2019-04-25
Limitations and caveats: Small study of a rare disease with tremendous patient variation.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Von Kossa Staining Per Unit Area of Dermis	up to 2 years	A blinded dermatopathologist graded skin biopsies on the density of Von Kossa staining, assessed changes in the amount of calcification of elastic fibers by assessing von Kossa staining per unit area of dermis
Secondary	Number of Participants With a 1-point Decrease of Target Lesions	up to 2 years	Changes in skin skin lesions observed through investigator evaluations and clinical photographs. The number of patients with a 1-point decrease of target lesions
Secondary	LogMar	2 years	Rate of disease progression - Changes observed through ophthalmologic examinations. (+) a decrease in this score indicates improvement of the disease (-) an increase in this score indicates worsening of the disease. LogMAR: logarithm of the minimum angle of resolution. The LogMAR scale converts the geometric sequence of a traditional chart to a linear scale. It measures visual acuity loss: positive values indicate vision loss, while negative values denote normal or better visual acuity.
Secondary	VAS - Visual Acuity Score	2 years	Rate of disease progression observed through ophthalmologic examinations.(+) an increase in this score indicates improvement of the disease (-) a decrease in this score indicates worsening of the disease. VAS ranges from 10 to 200, with higher score indicating poorer visual acuity.
Secondary	Central Retinal Thickness	2 years	Rate of disease progression observed through ophthalmologic examinations. (+) a decrease in this scores indicates improvement of the disease; (-) an increase in this scores indicates improvement of the disease.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Von Kossa Staining Per Unit Area of Dermis	up to 2 years	Estimate: Estimated change from baseline and its standard error (SEM). After 1 year=M12-Baseline, After 2 year=M24-Baseline; during 2nd year =M24-M12.	microns	MEAN
SECONDARY	Number of Participants With a 1-point Decrease of Target Lesions	up to 2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	LogMar	2 years		LogMar	MEAN
SECONDARY	VAS - Visual Acuity Score	2 years		units on a scale	MEAN
SECONDARY	Central Retinal Thickness	2 years		µm	MEAN

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Von Kossa Staining Per Unit Area of Dermis	Magnesium Oxide	After 1 year	-0.0033	Standard Error 0.0062	microns
Von Kossa Staining Per Unit Area of Dermis	Placebo	After 1 year	0.0010	Standard Error 0.0065	microns
Von Kossa Staining Per Unit Area of Dermis	Magnesium Oxide	during 2nd year	0.0087	Standard Error 0.0062	microns
Von Kossa Staining Per Unit Area of Dermis	Placebo	during 2nd year	0.0123	Standard Error 0.0070	microns
Von Kossa Staining Per Unit Area of Dermis	Magnesium Oxide	after 2 years	0.0054	Standard Error 0.0062	microns
Von Kossa Staining Per Unit Area of Dermis	Placebo	after 2 years	0.0132	Standard Error 0.0069	microns
Number of Participants With a 1-point Decrease of Target Lesions	Magnesium Oxide	After 1 year	2		Participants
Number of Participants With a 1-point Decrease of Target Lesions	Placebo	After 1 year	1		Participants
Number of Participants With a 1-point Decrease of Target Lesions	Magnesium Oxide	during 2nd year	8		Participants
Number of Participants With a 1-point Decrease of Target Lesions	Placebo	during 2nd year	6		Participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Placebo-controlled Period	STARTED	Magnesium Oxide	22
Placebo-controlled Period	STARTED	Placebo	22
Placebo-controlled Period	COMPLETED	Magnesium Oxide	21
Placebo-controlled Period	COMPLETED	Placebo	20
Placebo-controlled Period	NOT COMPLETED	Magnesium Oxide	1
Placebo-controlled Period	NOT COMPLETED	Placebo	2
Open-label Period	STARTED	Magnesium Oxide	21
Open-label Period	STARTED	Placebo	20
Open-label Period	COMPLETED	Magnesium Oxide	21
Open-label Period	COMPLETED	Placebo	18

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	Magnesium Oxide	10	22	14
other	Diarrhea	Gastrointestinal disorders	Placebo	9	22	9
other	Loose Stool	Gastrointestinal disorders	Magnesium Oxide	1	22	2
other	Loose Stool	Gastrointestinal disorders	Placebo	2	22	2
other	Abdominal Cramps	Gastrointestinal disorders	Magnesium Oxide	1	22	2
other	Abdominal Cramps	Gastrointestinal disorders	Placebo	0	22	0
other	Nausea	Gastrointestinal disorders	Magnesium Oxide	0	22	0
other	Nausea	Gastrointestinal disorders	Placebo	2	22	2
other	Flatulance	Gastrointestinal disorders	Magnesium Oxide	0	22	0
other	Flatulance	Gastrointestinal disorders	Placebo	2	22	2

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Magnesium Oxide	0	22
Total, all-cause mortality	Placebo	0	22
Total, other adverse events	Magnesium Oxide	11	22
Total, other adverse events	Placebo	11	22
Total, serious adverse events	Magnesium Oxide	0	22
Total, serious adverse events	Placebo	0	22

Source ClinicalTrials.gov

Papers15

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
580723	BACKGROUND	PubMed
1195509	BACKGROUND	PubMed
1838878	BACKGROUND	PubMed
2662695	BACKGROUND	PubMed
3359381	BACKGROUND	PubMed
3812346	BACKGROUND	PubMed
6375330	BACKGROUND	PubMed
6507474	BACKGROUND	PubMed
7013665	BACKGROUND	PubMed
7046115	BACKGROUND	PubMed

1 to 10 of 15

See all 15 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Magnesium Oxide vs Placebo: deaths from any cause	Trial comparisons
Magnesium Oxide vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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