Alagille SyndromeNCT00007033
Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
A study testing magnesium gluconate and magnesium sulfate in people with Alagille Syndrome and Cholestasis, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
OBJECTIVES: I. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Alagille Syndrome, Cholestasis, Biliary Atresia
- What is being tested?
- magnesium gluconate and magnesium sulfate
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Diagnosis of liver disease with chronic cholestasis Nonsyndromic intrahepatic cholestasis Alagille's syndrome Extrahepatic biliary atresia
- Direct bilirubin greater than 2 mg/dL OR Bile acids greater than 20 micromoles/L
- No hepatic decompensation defined as one or more of the following: Ascites Peripheral edema PT at least 4 seconds longer than control Albumin less than 3 g/dL
--Patient Characteristics--
- Renal: No significant renal disease
- Cardiovascular: No significant cardiovascular disease
- Pulmonary: No significant pulmonary disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
About this study
OBJECTIVES:
- Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease.
Read the detailed description
PROTOCOL OUTLINE:
Patients receive magnesium sulfate IV over 1 hour on day 3. Patients then receive oral magnesium gluconate supplementation daily. Treatment with magnesium sulfate repeats once at 3-6 months.
- Conditions
- Alagille Syndrome, Cholestasis, Biliary Atresia
- Being tested
- magnesium gluconate, magnesium sulfate
- Keywords
- Alagille syndrome, biliary atresia, cholestasis, gastrointestinal disorders, rare disease
- Medical subject headings
- Alagille Syndrome, Cholestasis, Biliary Atresia, Gastrointestinal Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium gluconateDrug
magnesium sulfateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2000 (estimated)
- Study startOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alagille SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Investigators
- James Heubi, Study chair, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007033
- Sponsor's protocol ID
- 199/15488
- Other IDs
- CHMC-C-91-3-7
- Status last verified
- Apr 2002
- First submitted
- 6 Dec 2000
- Last updated
- 22 Jan 2009
- Results posted
- No
Publications
Heubi JE, Wiechmann DA, Creutzinger V, Setchell KD, Squires R Jr, Couser R, Rhodes P. Tauroursodeoxycholic acid (TUDCA) in the prevention of total parenteral nutrition-associated liver disease. J Pediatr. 2002 Aug;141(2):237-42. doi: 10.1067/mpd.2002.125802.
PubMed 12183720
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
- ClinicalTrials.gov ID
- NCT00007033
- Acronym / sponsor ID
- 199/15488
- Conditions
- Alagille Syndrome, Cholestasis, Biliary Atresia
- Keywords
- Alagille syndrome, biliary atresia, cholestasis, gastrointestinal disorders, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- Oct 2000
- First posted
- 7 Dec 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease.
Detailed description
PROTOCOL OUTLINE:
Patients receive magnesium sulfate IV over 1 hour on day 3. Patients then receive oral magnesium gluconate supplementation daily. Treatment with magnesium sulfate repeats once at 3-6 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium gluconate | Drug | – |
| magnesium sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
- Results publication: PubMed 12183720Heubi JE, Wiechmann DA, Creutzinger V, Setchell KD, Squires R Jr, Couser R, Rhodes P. Tauroursodeoxycholic acid (TUDCA) in the prevention of total parenteral nutrition-associated liver disease. J Pediatr. 2002 Aug;141(2):237-42. doi: 10.1067/mpd.2002.125802.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Heubi study chair
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnesium gluconate and magnesium sulfate in people with Alagille Syndrome and Cholestasis, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00007033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2009.