Zinc and Bone Turnover Study in Adolescent Females

Sponsor

University of Georgia (Other)

Overall Status

Completed

CT.gov ID

NCT01892098

Collaborator

(none)

147

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Feb 1, 2007

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Serum Zinc [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 [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) [4 weeks]
Bone turnover marker procollagen type 1 amino-terminal propeptide,

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 11 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Georgia

Investigators

Principal Investigator: Richard D Lewis, PhD, The University of Georgia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Georgia

ClinicalTrials.gov Identifier:

NCT01892098

Other Study ID Numbers:

R03HD054630

First Posted:

Jul 3, 2013

Last Update Posted:

Jul 3, 2013

Last Verified:

Jul 1, 2013

Keywords provided by University of Georgia

Additional relevant MeSH terms:

Osteoporosis

Zinc Sulfate

Study Results

No Results Posted as of Jul 3, 2013