Zinc and Bone Turnover Study in Adolescent Females

NCT01892098 | Completed DMC

• 1 other identifier: R03HD054630
• Study Type: interventional
• Target: 147
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone; Growth; Osteoporosis

Keywords

Zinc; Bone; Adolescents; Growth

Outcome Measures

Primary Outcomes (3)

• Serum Zinc

  Serum Zinc will be measured at the Baseline and 4 week time point to determine effects of placebo vs. supplement.

  4 weeks

• 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

• procollagen type 1 amino-terminal propeptide (P1NP)

  Bone turnover marker procollagen type 1 amino-terminal propeptide,

  4 weeks

Study Arms (2)

Zinc Sulfate

ACTIVE COMPARATOR

Subjects enrolled in this arm will receive 9mg elemental zinc (23mg zn sulfate)/day for 4 weeks.

Dietary Supplement: Zinc Sulfate

Cellulose Pill

PLACEBO COMPARATOR

Subject enrolled in this arm will receive a placebo.

Dietary Supplement: Placebo

Interventions

Zinc Sulfate DIETARY_SUPPLEMENT

9mg elemental zinc via 23mg zinc sulfate/day

Zinc Sulfate

Placebo DIETARY_SUPPLEMENT

Cellulose pill given as placebo

Cellulose Pill

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Georgia: lead

Related Publications (3)

• Lobene AJ, Kindler JM, Jenkins NT, Pollock NK, Laing EM, Grider A, Lewis RD. Zinc Supplementation Does Not Alter Indicators of Insulin Secretion and Sensitivity in Black and White Female Adolescents. J Nutr. 2017 Jul;147(7):1296-1300. doi: 10.3945/jn.117.248013. Epub 2017 Jun 7.

  PMID: 28592518 DERIVED

• Kindler JM, Pollock NK, Laing EM, Jenkins NT, Oshri A, Isales C, Hamrick M, Lewis RD. Insulin Resistance Negatively Influences the Muscle-Dependent IGF-1-Bone Mass Relationship in Premenarcheal Girls. J Clin Endocrinol Metab. 2016 Jan;101(1):199-205. doi: 10.1210/jc.2015-3451. Epub 2015 Nov 17.

  PMID: 26574958 DERIVED

• Berger PK, Pollock NK, Laing EM, Chertin V, Bernard PJ, Grider A, Shapses SA, Ding KH, Isales CM, Lewis RD. Zinc Supplementation Increases Procollagen Type 1 Amino-Terminal Propeptide in Premenarcheal Girls: A Randomized Controlled Trial. J Nutr. 2015 Dec;145(12):2699-704. doi: 10.3945/jn.115.218792. Epub 2015 Oct 21.

  PMID: 26491117 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Richard D Lewis, PhD

  The University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 3, 2013
• Study Start: February 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 3, 2013

Record last verified: 2013-07