Behaviour Intervention to Decrease Melamine Exposure (Bidme)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Behavioral: One bag, stainless container

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: One big bag, no stainless container; No stainless container	Behavioral: One bag, stainless container
Active Comparator: One big bag with two stainless containers; Two stainless containers	Behavioral: One bag, stainless container

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease melamine excretion	3 days

Collaborators and Investigators

• Sponsor: Ming-Tsang Wu
• Investigators: Principal Investigator: Ming-Tsang Wu, MD, ScD, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Estimate): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 20, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Melamine; Melamine tableware
• Other Study ID Numbers: KMU-DT103004 (Other Identifier: Kaohsiung Medical University Hospital)