Patients with decreased serum ferritin levels
Conditions
Interventions
Patients with decreased serum ferritin levels (<30 ng/mL) are given iron orally.
Sponsors
Yuki Takahashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients visiting the outpatient psychiatry department of Tokai University Hospital or Aikou Hospital. 2. Age between 6 and 12 years old. 3. Ease of fatigue (moderate or severe on the Japanese version of the Brief Fatigue Inventory) or insomnia (42 or more points on the Japanese version of the Children's Sleep Habits Questionnaire (CSHQ-J)) 4. Serum ferritin level less than 30 ng/mL. 5. Patients who have received a full explanation of their participation in this study and have obtained written consent from the research subjects and their guardians.
Exclusion criteria
Exclusion criteria: 1. those taking psychotropic drugs (antipsychotics and antidepressants, anxiolytics, sleep medications, antiepileptic drugs) or steroids 2. have an active malignancy or known infectious, autoimmune, or inflammatory disease 3. Hb less than 12 g/dl 4. other patients who are deemed inappropriate by the physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. CGI-I: 4-9 weeks,12 weeks,24 weeks 2. CSHQ-J: before drug administration,12 weeks,24 weeks 3. Japanese version of Brief Fatigue Inventory: before drug administration,12 weeks,24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hematology (Hb, MCV): Baseline (0 week),12 wee ks (including 3 weeks before and after),24 weeks (including 3 weeks before and after) 2. Hematology (Fe, TIBC, ferritin): Baseline (0 week),12 weeks (including 3 weeks before and after ), 24 weeks (including 3 weeks before and after) 3. QCD:4-9 weeks,12 weeks,24 weeks 4. CGI-S: before drug administration, 4-9 weeks,12 weeks,24 weeks 5. POMS2: before drug administration,12 weeks,24 weeks | — |
Contacts
Public ContactTakahashi Yuki
Tokai University Hospital
Outcome results
None listed