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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
Sponsor:
Information provided by (Responsible Party):
University of Georgia

Brief Summary:
The purpose of the study is to determine the effects of zinc supplementation on bone growth over four weeks. Participants will agree to attend two visits to our laboratory and at each will complete blood and urine samples, questionnaires related to diet and physical activity and will receive a bone scan at the first appointment.

Condition or disease Intervention/treatment Phase
Bone Growth Osteoporosis Dietary Supplement: Zinc Sulfate Dietary Supplement: Placebo Not Applicable

Detailed Description:
Significant accomplishments have been achieved with respect to our understanding of calcium and vitamin D and skeletal health, yet a body of scientific evidence has also identified understudied nutrients that have potential for reducing the burden of osteoporosis. Zinc has important roles in bone metabolism and there are indications from animal and human studies that beyond correcting skeletal and growth impairments under deficiency conditions, supplementation with zinc may have a bone health-promoting role. It has been postulated that the action of zinc on bone metabolism is partially mediated by Insulin-like growth factor one (IGF-I). Prior to undertaking a long-term bone trial, a short-term zinc supplementation trial is proposed to first determine if zinc alters intermediate markers of bone metabolism in healthy, early pubertal females (9-10.5 years of age). We hypothesize that healthy females receiving 24 mg zinc /day over 4 weeks will have elevated serum markers of bone formation and plasma growth factors compared to those receiving placebo. We further hypothesize that the differences between the zinc and placebo groups will vary by race. To test these hypotheses, we will screen early pubertal females to assure similar maturational status and conduct a 3-week, randomized, double-blind, placebo-controlled trial with a zinc supplementation (zinc sulfate; n=80) and a placebo (n=80) arm. The groups will be further divided by race (non-Hispanic White and non-Hispanic Black; n=40 per group). The specific aims are to determine if early pubertal females supplemented with zinc compared to those receiving placebo will have: 1) greater increases in markers of bone turnover favoring bone formation; 2) greater increases in plasma IGF-1 and IGFBP-3; and 3) changes in bone turnover markers, IGF-1 and IGFBP-3 that differ by race. In addition, anthropometric measures, maturity offset, sexual maturation, erythrocyte superoxide dismutase activity, ceruloplasmin, dietary intakes and physical activity will be determined. Findings from this study will provide preliminary evidence of whether supplementation with zinc is a viable nutrition strategy to improve biochemical indices of bone turnover and growth factors in young females. Moreover, the results will help determine if a long-term clinical bone trial is warranted to more definitely assess the potential for supplemental zinc to reduce the risk for osteoporosis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. procollagen type 1 amino-terminal propeptide (P1NP) [ Time Frame: 4 weeks ]
    Bone turnover marker procollagen type 1 amino-terminal propeptide,



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Female
  • Ages 9-11
  • Pre-menarchal
  • Caucasian or African American

Exclusion Criteria:

  • Menses
  • Disease known to affect bone
  • Drugs known to affect bone
  • Vitamin/mineral supplements

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Georgia
Investigators
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Principal Investigator: Richard D Lewis, PhD The University of Georgia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Georgia
ClinicalTrials.gov Identifier: NCT01892098     History of Changes
Other Study ID Numbers: R03HD054630 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013
Keywords provided by University of Georgia:
Zinc
Bone
Adolescents
Growth
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents