BoneNCT01892098
Zinc and Bone Turnover Study in Adolescent Females
A study testing Zinc Sulfate in people with Bone and Growth, run by University of Georgia.
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… Read more about this study
- Who is it for?
- Ages 9 to 11 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone, Growth, Osteoporosis
- What is being tested?
- Zinc Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy
- Female
- Ages 9-11
- Pre-menarchal
- Caucasian or African American
Who cannot join
- Menses
- Disease known to affect bone
- Drugs known to affect bone
- Vitamin/mineral supplements
About this study
Official title: Supplemental Zinc and Bone Turnover in Early Pubertal 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.
Read the 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.
- Conditions
- Bone, Growth, Osteoporosis
- Being tested
- Zinc Sulfate, Placebo
- Keywords
- Zinc, Bone, Adolescents, Growth
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SulfateDietary supplement
9mg elemental zinc via 23mg zinc sulfate/day
PlaceboDietary supplement
Cellulose pill given as placebo
| Study group | Role | What they receive |
|---|---|---|
| Zinc Sulfate | Active comparator | Subjects enrolled in this arm will receive 9mg elemental zinc (23mg zn sulfate)/day for 4 weeks. Receives: Dietary Supplement: Zinc Sulfate |
| Cellulose Pill | Placebo comparator | Subject enrolled in this arm will receive a placebo. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Zinc
Serum Zinc will be measured at the Baseline and 4 week time point to determine effects of placebo vs. supplement.
Measured: 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.
Measured: 4 weeks
procollagen type 1 amino-terminal propeptide (P1NP)
Bone turnover marker procollagen type 1 amino-terminal propeptide,
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startFeb 2007
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard D Lewis, PhD, Principal investigator, The University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892098
- Sponsor's protocol ID
- R03HD054630
- Status last verified
- Jul 2013
- First submitted
- 28 Jun 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28592518Kindler 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.
PubMed 26574958Berger 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.
PubMed 26491117
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Zinc and Bone Turnover in Early Pubertal Females
- ClinicalTrials.gov ID
- NCT01892098
- Acronym / sponsor ID
- R03HD054630
- Conditions
- Bone, Growth, Osteoporosis
- Keywords
- Zinc, Bone, Adolescents, Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc Sulfate | Active comparator | Dietary Supplement: Zinc SulfateSubjects enrolled in this arm will receive 9mg elemental zinc (23mg zn sulfate)/day for 4 weeks. |
| Cellulose Pill | Placebo comparator | Dietary Supplement: PlaceboSubject enrolled in this arm will receive a placebo. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy
- Female
- Ages 9-11
- Pre-menarchal
- Caucasian or African American
Key exclusion criteria (4 listed)
- Menses
- Disease known to affect bone
- Drugs known to affect bone
- Vitamin/mineral supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Sulfate9mg elemental zinc via 23mg zinc sulfate/day | Dietary supplement | Zinc Sulfate |
| PlaceboCellulose pill given as placebo | Dietary supplement | Cellulose Pill |
Primary outcome
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.
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.
procollagen type 1 amino-terminal propeptide (P1NP)
Time frame: 4 weeks
Bone turnover marker procollagen type 1 amino-terminal propeptide,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Derived from this study: PubMed 28592518Lobene 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.
- Derived from this study: PubMed 26574958Kindler 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.
- Derived from this study: PubMed 26491117Berger 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.
Related trials for Bone
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard D Lewis, PhD principal investigator
The University of Georgia
Questions about this trial
What is this clinical trial studying?
A study testing Zinc Sulfate in people with Bone and Growth, run by University of Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Zinc (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892098, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.