Endocrine System Diseases Clinical Trial
Official title:
Prevalence of Endocrine Disorders Among Children Exposed to Lavender Essential Oil and Tea Tree Essential Oils
Verified date | October 2021 |
Source | Franklin School of Integrative Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to explore the potential for an association between the development of prepubertal gynecomastia and history exposure to lavender essential oil, tea tree essential oil, and other essential oils.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | December 31, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 2 Years to 15 Years |
Eligibility | Inclusion Criteria: - Parent of child aged 2-15 living in the United States Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
United States | Franklin Health Research Center | Franklin | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Franklin School of Integrative Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lifetime prevalence of prepubertal gynecomastia | The number of participants who were exposed to lavender and tea tree essential oils and had ever experienced prepubertal gynecomastia | Baseline | |
Primary | Lifetime prevalence of precocious puberty | The number of participants who were exposed to lavender and tea tree essential oils and experienced prepubertal gynecomastia | Baseline | |
Primary | Endocrine Disruption - Comparison between exposed and unexposed | The difference in rates of endocrine disorders between children who were exposed to lavender or tea tree essential oil and those who were not. Exposure is measured using the Aromatic Plant Ingredient and Child Health Survey (APICHS), which measures total exposure, providing a continuous variable ranging from 0 to unlimited exposures, and a dichotomous yes/no exposure outcome variable. | Baseline |
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