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Completed

NCT Number: NCT01892098

Zinc and Bone Turnover Study in Adolescent Females

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.

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Key information

Age range

9 year–11 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zinc sulfate

Dietary Supplement

9mg elemental zinc via 23mg zinc sulfate/day

Placebo

Dietary Supplement

Cellulose pill given as placebo

Primary outcomes

  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,

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Registry information

Official study title

Supplemental Zinc and Bone Turnover in Early Pubertal Females

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 3, 2013
Registry last updated
Jul 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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