Zinc and Bone Turnover Study in Adolescent Females
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|ClinicalTrials.gov Identifier: NCT01892098|
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : July 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bone Growth Osteoporosis||Dietary Supplement: Zinc Sulfate Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Supplemental Zinc and Bone Turnover in Early Pubertal Females|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||June 2010|
Active Comparator: Zinc Sulfate
Subjects enrolled in this arm will receive 9mg elemental zinc (23mg zn sulfate)/day for 4 weeks.
Dietary Supplement: Zinc Sulfate
9mg elemental zinc via 23mg zinc sulfate/day
Placebo Comparator: Cellulose Pill
Subject enrolled in this arm will receive a placebo.
Dietary Supplement: Placebo
Cellulose pill given as placebo
- Serum Zinc [ Time Frame: 4 weeks ]Serum Zinc will be measured at the Baseline and 4 week time point to determine effects of placebo vs. supplement.
- Plasma IGF-1 and IGFBP-3 [ Time Frame: 4 weeks ]Plasma IGF-1 and IGFBP-3 will be measured at Baseline and 4-weeks and analyzed using ELISA to determine changes.
- procollagen type 1 amino-terminal propeptide (P1NP) [ Time Frame: 4 weeks ]Bone turnover marker procollagen type 1 amino-terminal propeptide,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892098
|Principal Investigator:||Richard D Lewis, PhD||The University of Georgia|