Behaviour Intervention to Decrease Melamine Exposure

NCT ID: NCT02251405

Last Updated: 2014-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2014-10-31

Brief Summary

One source of melamine exposure in the modern life is from the use of melamine tableware. This study examines whether the use of stainless steel containers can decrease melamine exposure in the daily life. The investigators hypothesize that, compared to those without use of stainless steel containers, university student volunteers with use of stainless steel containers excrete significantly lower melamine levels in urine.

Detailed Description

Study subjects:

Two tiers:

1. 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)

2. 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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

One big bag, no stainless container

No stainless container

Group Type: PLACEBO_COMPARATOR

One bag, stainless container

Intervention Type: BEHAVIORAL

One big bag with two stainless containers

Two stainless containers

Group Type: ACTIVE_COMPARATOR

One bag, stainless container

Intervention Type: BEHAVIORAL

Interventions

One bag, stainless container

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ming-Tsang Wu

OTHER

Sponsor Role: lead

Responsible Party

Ming-Tsang Wu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ming-Tsang Wu, MD, ScD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

Kaohsiung Medical University

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KMU-DT103004

Identifier Type: OTHER

Identifier Source: secondary_id

KMU-DT103004

Identifier Type: -

Identifier Source: org_study_id