DRKS00015225Completed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 enrollmentStarted: August 14, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 77
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
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):
- •- Adult males and females (age >18 years) without Hypophosphatasia
- •- Signed informed consent
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
- •- Intake of nutritional supplements (exception: Vit.D, magnesium) (this exclusion criteria doesn’t apply to section 1)
- •- Pregnancy or lactation
- •- Addiction to drugs or alcohol
- •- Current participation in another clinical study
- •- Withdrawal of consent
Investigators
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