DRKS00015225
Completed
未知
utritional Status and dietary Effects on Phosphorous metabolism and clinical Symptoms in Hypophosphatasia
Klinische StudieneinheitOrthopädische Klinik König-Ludwig-HausLehrstuhl der Universität Würzburg0 sites77 target enrollmentAugust 14, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- E83.3
- Sponsor
- Klinische StudieneinheitOrthopädische Klinik König-Ludwig-HausLehrstuhl der Universität Würzburg
- Enrollment
- 77
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Section I,II:
- •\- Adult males and females (age \>18 years)
- •\- Established diagnosis of Hypophosphatasia
- •\- Reduced Serum/Plasma ALP\-Activity below age and sex specific reference range of the respective test kit applied (measured at least twice with a minimum 4 week interval)
- •\- At least one of the items below
- •\>Genetically confirmed ALPL\-Mutation
- •\>Elevated PLP (urine or serum), above ULN
- •\>Symptoms of the disease
- •\- Signed informed consent
- •Section I (control group):
Exclusion Criteria
- •Section I,II:
- •\- Severe chronic diseases
- •\>Renal insufficiency, CKD 4 \+ 5 (eGFR\<30ml/min/KO)
- •\>Current or past history of solid or haematological neoplasia; patients are eligible when clinically stable (as judged by the investigator) and diagnosis of this neoplasia dates back \> 5 years.
- •\- Inflammatory bowel disease, or history of colostomy or small or large intestine bowel surgery where resection was performed
- •\- Coagulopathy
- •\- Intake of phosphate binders or Dialysis
- •\- Ongoing treatment with glucocorticoids \>7,5mg/d prednisolone\-equivalent
- •\- Current/previous treatment with Asfotase alfa (ERT) (section I), Current/recent treatment with Asfotase alfa (ERT) within the last 3 months before enrollment
- •\- Regular use of laxatives
Outcomes
Primary Outcomes
Not specified
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