Healthy Children and Their Main-care GiverNCT02724722
Family-based Childhood Behavior Intervention to Decrease Environmental Melamine and Phthalate Exposure
A study testing Assigned intervention in people with Healthy Children and Their Main-care Giver, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Melamine and phthalates are environmental emerging chemicals, which are ubiquitously present in the public and easily contacted by children through air, foods, and skin. This study aims to examine whether the use of family-based behavior intervention by providing simple flyers plus face-to-face health education… Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children and Their Main-care Giver
- What is being tested?
- Assigned intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 3-18-yrs healthy children and their main-care givers (i.e., mothers or grandmothers)
Who cannot join
- Children with any hormone treatment or major chronic diseases such as cancer
Trial locations and contacts
1 site in 1 country.
About this study
Melamine and phthalates are environmental emerging chemicals, which are ubiquitously present in the public and easily contacted by children through air, foods, and skin. This study aims to examine whether the use of family-based behavior intervention by providing simple flyers plus face-to-face health education point-by-point and give one bag containing stainless steel-made tableware for eating out use to study children's mothers or main-care givers can significantly decrease melamine and phthalates exposure by measuring urinary melamine and metabolites of phthalates (especially DEHP metabolites) in study children and their mothers or main-care givers, when compared to those provided simple flyers only.
Read the 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.
- Being tested
- Assigned intervention, No intervention
- Keywords
- melamine, phthalate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned interventionBehavioural
a simple flyer plus face-to-face health education and give one bag containing stainless steel-made tableware for eating out use
No interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | a simple flyer in one empty bag with face-to-face health education Receives: Behavioral: Assigned intervention |
| No Intervention | Placebo comparator | a simple flyer in one empty bag with no face-to-face health education Receives: Behavioral: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary excretion of melamine
Measured: 2 weeks
urinary excretion of five DEHP metabolites (MEHP, 5OH-MEHP, 5oxo-MEHP, 5carboxy-MEPP, and 2carboxy-MMHP)
Measured: 2 weeks
Secondary outcomes (4)
oxidative stress markers (8-OHdG, MDA)
Measured: 6 months
other six phthalate metabolites of MnBP, MiBP, MEP, MBzP, MMP, and MiNP
Measured: 2 weeks
oxidative stress markers (8-OHdG, MDA)
Measured: one year
renal injury markers (NAG, microalbumin, beta-2-microglobulin)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy Children and Their Main-care GiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Tsang Wu, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Ming-Tsang Wu, MD, ScD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724722
- Sponsor's protocol ID
- KMU-TP103A23
- Status last verified
- Sep 2016
- First submitted
- 10 Mar 2015
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23383031Wu 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.
PubMed 24191740
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-based Childhood Behavior Intervention to Decrease Environmental Melamine and Phthalate Exposure
- ClinicalTrials.gov ID
- NCT02724722
- Acronym / sponsor ID
- KMU-TP103A23
- Keywords
- melamine, phthalate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Melamine and phthalates are environmental emerging chemicals, which are ubiquitously present in the public and easily contacted by children through air, foods, and skin. This study aims to examine whether the use of family-based behavior intervention by providing simple flyers plus face-to-face health education point-by-point and give one bag containing stainless steel-made tableware for eating out use to study children's mothers or main-care givers can significantly decrease melamine and phthalates exposure by measuring urinary melamine and metabolites of phthalates (especially DEHP metabolites) in study children and their mothers or main-care givers, when compared to those provided simple flyers only.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Assigned interventiona simple flyer in one empty bag with face-to-face health education |
| No Intervention | Placebo comparator | Behavioral: No interventiona simple flyer in one empty bag with no face-to-face health education |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 3-18-yrs healthy children and their main-care givers (i.e., mothers or grandmothers)
Key exclusion criteria (1 listed)
- Children with any hormone treatment or major chronic diseases such as cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assigned interventiona simple flyer plus face-to-face health education and give one bag containing stainless steel-made tableware for eating out use | Behavioural | Intervention |
| No interventiona simple flyer only with no face-to-face health education and give one bag not containing stainless steel-made tableware for eating out use | Behavioural | No Intervention |
Primary outcome
urinary excretion of melamine
Time frame: 2 weeks
urinary excretion of five DEHP metabolites (MEHP, 5OH-MEHP, 5oxo-MEHP, 5carboxy-MEPP, and 2carboxy-MMHP)
Time frame: 2 weeks
4 secondary outcomes
oxidative stress markers (8-OHdG, MDA)
Time frame: 6 months
other six phthalate metabolites of MnBP, MiBP, MEP, MBzP, MMP, and MiNP
Time frame: 2 weeks
oxidative stress markers (8-OHdG, MDA)
Time frame: one year
renal injury markers (NAG, microalbumin, beta-2-microglobulin)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Background: PubMed 23383031Wu 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.
- Background: PubMed 24191740Wu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Tsang Wu, MD, ScD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned intervention in people with Healthy Children and Their Main-care Giver, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary excretion of melamine (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724722, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016; AzTrials last refreshed its copy on 27 Oct 2026.