Family-based Childhood Behavior Intervention to Decrease Environmental Melamine and Phthalate Exposure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study subjects: Between May 31 and June 17, 2011, 108 children visited the special Phthalates Clinic for Children (PCC) at Kaohsiung Medical University Hospital (KMUH). Thirteen children whose age was older than 10 years, one girl with a history of hormone (leuprorelin) treatment, and thirty-four whose parents did not sign informed consents were excluded. The rest of 60 children are eligible to participate in this study. Because 37 out of the 60 potential study children did provide enough urine for the analyses of phthalates metabolites in our previous study [Wu et al., 2013a; Wu et al., 2013b], in this study, the investigators focus on the 37 study children. After the contact by phone, 24 study children and their mothers or main-care givers are willing to participate in this study intervention.
Study protocol: This is a family-based randomized intervention. The investigators will conduct this study for 2 weeks follow up. The investigators randomly assign 12 study children and their main-care givers (i.e., mothers or grandmothers) to a intervention group and another 12 to a control group. Intervention group means study children and their main-care givers (i.e., mothers or grandmothers) will receive face-to-face health education, besides provided the simple flyers and give one bag containing stainless steel-made tableware for eating out use, how to avoid environmental exposure to melamine and phthalate chemicals based on the evidence-based data from the investigators' laboratory and other researchers. The investigators only provide the simple flyers in a empty bag to the control group. The investigators will collect two one-spot urine samples from two consecutive mornings of the study children and their main-care givers, usually mother or grandmothers, at the baseline. Blood samples of the children were also collected measurement of endocrine profile, including TSH, T4, FT4, T3, and E2. After 2 weeks, another two one-spot urine samples from two consecutive mornings of the study investigators will collect two one-spot urine samples from two consecutive mornings of the study children and their main-care givers, usually mother or grandmothers, every 3 months for analyses.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 3-18-yrs healthy children and their main-care givers (i.e., mothers or grandmothers)
Exclusion Criteria:
- Children with any hormone treatment or major chronic diseases such as cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
a simple flyer in one empty bag with face-to-face health education
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a simple flyer plus face-to-face health education and give one bag containing stainless steel-made tableware for eating out use
|
|
Placebo Comparator: No Intervention
a simple flyer in one empty bag with no face-to-face health education
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a simple flyer only with no face-to-face health education and give one bag not containing stainless steel-made tableware for eating out use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
urinary excretion of melamine
Time Frame: 2 weeks
|
2 weeks
|
|
urinary excretion of five DEHP metabolites (MEHP, 5OH-MEHP, 5oxo-MEHP, 5carboxy-MEPP, and 2carboxy-MMHP)
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
oxidative stress markers (8-OHdG, MDA)
Time Frame: 6 months
|
6 months
|
|
other six phthalate metabolites of MnBP, MiBP, MEP, MBzP, MMP, and MiNP
Time Frame: 2 weeks
|
2 weeks
|
|
oxidative stress markers (8-OHdG, MDA)
Time Frame: one year
|
one year
|
|
renal injury markers (NAG, microalbumin, beta-2-microglobulin)
Time Frame: one year
|
one year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ming-Tsang Wu, MD, ScD, Kaohsiung Medical University
Publications and helpful links
General Publications
- Wu MT, Wu CF, Chen BH, Chen EK, Chen YL, Shiea J, Lee WT, Chao MC, Wu JR. Intake of phthalate-tainted foods alters thyroid functions in Taiwanese children. PLoS One. 2013;8(1):e55005. doi: 10.1371/journal.pone.0055005. Epub 2013 Jan 30.
- Wu CF, Chen BH, Shiea J, Chen EK, Liu CK, Chao MC, Ho CK, Wu JR, Wu MT. Temporal changes of urinary oxidative metabolites of di(2-ethylhexyl)phthalate after the 2011 phthalate incident in Taiwanese children: findings of a six month follow-up. Environ Sci Technol. 2013 Dec 3;47(23):13754-62. doi: 10.1021/es403141u. Epub 2013 Nov 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
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