Zinc and Bone Turnover Study in Adolescent Females

Osteoporosis Clinical Trial

Official title:

Supplemental Zinc and Bone Turnover in Early Pubertal Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892098
• Other study ID #: R03HD054630
• Status: Completed
• Phase: N/A
• First received: June 28, 2013
• Last updated: July 2, 2013
• Start date: February 2007
• Est. completion date: June 2010

Study information

• Verified date: July 2013
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone
• Growth
• Osteoporosis

Intervention

Dietary Supplement:
• Zinc Sulfate
9mg elemental zinc via 23mg zinc sulfate/day
• Placebo
Cellulose pill given as placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Zinc	Serum Zinc will be measured at the Baseline and 4 week time point to determine effects of placebo vs. supplement.	4 weeks	No
Primary	Plasma IGF-1 and IGFBP-3	Plasma IGF-1 and IGFBP-3 will be measured at Baseline and 4-weeks and analyzed using ELISA to determine changes.	4 weeks	No
Primary	procollagen type 1 amino-terminal propeptide (P1NP)	Bone turnover marker procollagen type 1 amino-terminal propeptide,	4 weeks	No