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Clinical Trials/DRKS00015225
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

Sponsor
Klinische StudieneinheitOrthopädische Klinik König-Ludwig-HausLehrstuhl der Universität Würzburg

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