Hypozincemia
Conditions
Interventions
The dose of NPC-02 granules will be determined by the weight and the age of patients, and it will be administered twice a day at 30-60 minutes after morning and evennge meals
Sponsors
Division of Gastroenterology Department of Medical Subspecialties National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient whose fasting serum zinc concentration are above 30 microgram/dL and under 70 microgram/dL both at the time and within 8 weeks before registration 2. Data from original medical record which was documented within 8 weeks and over 1week before registration can be used for patient screening 3. Serum zinc concentration at the time and within 8 weeks before registration needs to be at least 1 week apart 4. Fasting is defined as equal or more than 4 hours after meal or tube feeding 5. Patient whose age at the time of registration is above 1 month and under 18 year-olds. No limitation with sex, or setting (outpatient/hospitalized). Premature infant whose corrected age is less than 1 month is excluded.) 6. Written consent to participate in this clinical trial must be obtained from legal guardian
Exclusion criteria
Exclusion criteria: 1. Patient who is judged by investigator to have malabsorption (short gut syndrome, post-intestinal resection, deletion of ZIP4 gene, etc.) 2. Patient whose serum albumin is no more than 80% of institutional range 3. Patient who receives parenteral nutrition at the time or within 8 weeks of registration 4. Patient who may require parenteral nutrition or fasting during clinical trial (registration-last visit or termination of trial) 5. Patient who has taken prohibited zinc containing medicine or supplement within 12 weeks before registration 6. Patient applying zinc containing dermatological preparations 7. Patient whose renal function is impaired (estimated glomerular infiltration rate < 60 mL/min/1.73m2) 8. Patient whose hepatobiliary enzymes (AST, ALT, GGTP) or amylase is more than twice the institutional normal range 9. Patient with known allergy or hypersensitivity to zinc containing medical products (including supplement) 10. Patient with malignant tumor 11. Patient with severe heart disease, hematological disorder, etc. 12. Woman after menarche who are pregnant, suspicious of pregnant, wishing to get pregnant, or lactating 13. Patient who participated in other clinical trials within 12 weeks before registration 14. Patient who are judged unsuitable for this clinical trial by the conducting physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients whose serum zinc concentration reached above 80 microgram/dL after 8 weeks administration of NPC-02 with the same dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change of serum zinc concentration 2. Proportion of zinc dose to reach the serum zinc concentration above 80 microgram/dL 3. Proportion of zinc dose required to raise the serum zinc concentration above 15 microgram/dL from the original concentration 4. Symptoms associated with hypozincemia | — |
Countries
Japan
Contacts
Public ContactMayumi Sako
National Center for Child Health and Development Division for Clinical Trials, Department of Clinical Research
Outcome results
None listed