Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT01660503
Eligibility Criteria:
Inclusion Criteria:
* Healthy adolescent Caucasian girls between the ages of 12-14. This population has been chosen because they exhibit higher risk for osteoporosis later in life.
Exclusion Criteria:
* Habitual dietary patterns including less than 550 and greater than 1500 mg Ca per day. This represents the 5th and 95th percentile of usual intake of girls 9-13 y in the US.
* History of smoking, alcohol use, illegal or non-prescription drug use
* History of disordered calcium or bone metabolism e.g. Paget's disease, hyper or hypo-calcemia
* History of gastrointestinal diseases (Crohn's, celiac, inflammatory bowel disease)
* History of diseases that affect kidney or liver function.
* Body Mass Index (BMI) less than 5th percentile for age or greater than the 90th percentile for age
* Having a broken bone within the last 6 months.
* Regular consumption of foods or supplements containing prebiotics or probiotics
* History of pregnancy or use of contraceptives
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
9 Years
Maximum Age:
13 Years
Study:
NCT01660503
Study Brief:
Protocol Section:
NCT01660503