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:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT01066806
Eligibility Criteria:
Inclusion Criteria:
* Age 13-14 years old (must be this age when consent is signed)
* Above the 50th percentile for BMI
* Above the 85th percentile for BMI with approval from their primary physician
* At least one and one- half years post menarche
* Habitual dietary calcium intake of 600mg/d or less as assessed by 3 day diet diary. This will be inclusive of supplemental calcium and dietary intake.
* Willingness to increase dietary calcium (low fat \[skim, 1%, 2%\] milk or yogurt) for one year
Exclusion Criteria:
* Menarche prior to age 10
* History of lactose intolerance or milk allergy
* Weight \>300 pounds
* BMI \> 97 percentile for age and gender
* Pregnancy
* Chronic disease or disorder like diabetes, polycystic ovarian syndrome, thyroid disease, seizures or cancer (cancer is ok if it has been \>10 years)
* Use of steroids like prednisone, prednisolone, hydrocortisone, Flovent, Advair, or Nasonex
* Use of weight reducing medications like Meredia, alli, Dexatrim or Xenical
* Use of contraceptives like Yasmin, Ortho Tri-Cyclen, Apri, Aviane or Depo-Provera for any reason, including acne (see inclusive list)
* Use of acne medications like Accutane or high dose Vitamin A
* Use of ADHD medications like Adderall, Ritalin, Concerta. (Per Dr. Ramaswamy-Straterra OK) (see inclusive list)
* Use of seizure medications like Lamictal or Phenobarb (see inclusive list)
* Use of anti-depressants like Prozac or Effexor (see inclusive list)
* Diagnosed eating disorder
* Dieting behavior with weight loss \> 10 pounds in the last 3 months (IF YES, consult with Project Manager)
* Metal in the skeleton (pins, rods, etc)
* Sibling of a child who is or has been on a dietary study in the last 5 years
* Total body BMC Z-score below -2.0 at baseline
* Participating in other ongoing research protocols
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
13 Years
Maximum Age:
14 Years
Study:
NCT01066806
Study Brief:
Protocol Section:
NCT01066806