- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02251405
Behaviour Intervention to Decrease Melamine Exposure (Bidme)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Study subjects:
Two tiers:
- Recruit 88 student volunteers from two university buildings and collect their morning one-spot urine specimens for 3 consecutive days (44 students in each building (Building A and Building B)
- Select appropriate study subjects with high excretion of urinary melamine and with consuming melamine tableware containing hot water or hot soup by questionnaire in the past 3 days for intervention.
Study protocol:
This is a cluster randomized crossover intervention. We will conduct this study for 9 days and each experimental step lasts for 3 days. We randomly assign one building with 8 appropriate study subjects to a serial of control-intervention-intervention steps and another building with also 8 appropriate study subjects to a serial of control-control-intervention steps. Intervention step means study subjects will carry one big bag containing two stainless containers, one stainless spoon, and one stainless chopstick and use them for each meal during the trial (Some subjects will need to take pictures randomly and email back before the meal). Control means study subjects will carry one big bag without those stainless container, spoon, and chopstick and only use the containers provided by vendors for each meal during the trial (Some subjects will need to take pictures randomly and email back before the meal to check their adherence). Collect 24-hr urine samples for 9 days for melamine levels.
Inclusion criteria: 20-30 healthy students Exclusion criteria: Subjects with cancer, hypertension, diabetes, chronic hepatic or renal diseases, including urinary tract infection, or renal stones; Family history of renal stones; Body weight less than 50 kg.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 20-30-yrs healthy students
Exclusion Criteria:
- Subjects with cancer, hypertension, diabetes, chronic hepatic or renal diseases, renal stones;
- Family history of renal stones;
- Body weight less than 50 kg.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: One big bag, no stainless container
No stainless container
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Aktiv komparator: One big bag with two stainless containers
Two stainless containers
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Decrease melamine excretion
Tidsramme: 3 days
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3 days
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ming-Tsang Wu, MD, ScD, Kaohsiung Medical University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- KMU-DT103004 (Anden identifikator: Kaohsiung Medical University Hospital)
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Kliniske forsøg med One bag, stainless container
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Ospedale Santa Maria AnnunziataAfsluttet