OsteoporosisNCT01564238
Effect of Sodium Intake on Calcium Retention in Girls
A study testing Low Na diet (1.3 g/d) and High sodium diet (3.8 g/d) in people with Osteoporosis, run by Purdue University at 1 site in United States.
Trial summary
Optimal calcium retention is important for building bone mass within the genetic potential, a key to reducing risk of osteoporosis later in life. Calcium retention is high during the rapid growth period. Read more about this study
- Who is it for?
- Ages 11 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Low Na diet (1.3 g/d) and High sodium diet (3.8 g/d)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Aug 2000
- 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 11 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- White or black race (both parents and grandparents had to be white or black to be eligible in the study).
Who cannot join
- < 11 or > 15 years
- body mass index (BMI) of < 15th or > 85th percentile for age
- history of amenorrhea, pregnancy or abortion, eating disorders, oral contraceptive or tobacco use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sodium Intake on Calcium Retention in Black and White Adolescent Girls.
Optimal calcium retention is important for building bone mass within the genetic potential, a key to reducing risk of osteoporosis later in life. Calcium retention is high during the rapid growth period. The investigators know that urinary calcium is affected by sodium intake but the investigators do not know the effects of sodium intake during the growth spurt or the differences in calcium retention between blacks and whites. Our hypothesis was that a high dietary sodium increases the calcium intakes required for optimal calcium retention in both black and white adolescent girls. The investigators tested calcium retention while girls consumed a low and high sodium diet during three week periods. The subjects were housed in a Purdue fraternity house during the summer and they were supervised at all times by trained staff. During the summer of 1999, subjects consumed diets with 2 levels of dietary Na+ with a fixed diet low in calcium. On the next summer, they switched to a high calcium diet. Subjects collected fecal and urine daily for 20 days. Other measurements included daily body weight, blood pressure every other day, blood sample at the end of each session. Baseline measures included bone mass, self-assessment of pubertal development, a physical examination and diet history.
Read the detailed description
Optimal calcium retention is a prerequisite for building maximal peak bone mass within the genetic potential, a key to reducing risk of osteoporosis later in life. The investigators have determined that maximal calcium retention averages 423 mg/day during the period of rapid skeletal accretion in white girls at a mean dietary calcium intake of 1300 mg/d. Urinary calcium explains more than 50% of the variance in calcium retention. However, urinary sodium (i.e. sodium intake)is a major determinant of urinary calcium excretion and the effect of sodium intake on maximal calcium retention is not known. Nor is its effect known in black adolescents who have higher bone density and lower calcium excretion than white adolescents.
The primary aim was to test the hypothesis that high dietary sodium increases the calcium intakes required for optimal calcium retention in both black and white adolescent girls. Calcium retention was measured at two levels of dietary sodium in a randomized crossover design on one of two levels of dietary calcium intake in black and white adolescent girls during three week metabolic periods. The investigators hypothesized that the mechanisms which regulate sodium reabsorption in the renal tubules also regulate calcium retention. Increased incidence of hypertension in blacks compared to whites has been attributed to increased sodium retention. Sodium intake induced changes in calcium and sodium retention in both races were related to changes in sodium handling (plasma renin activity, serum aldosterone, and salt sensitivity) and calcium regulating hormones, biomarkers of bone turnover and bone mass.
The subjects were resident in a Purdue fraternity house, which was transformed during the summer into a metabolic unit. Subjects were supervised at all times by trained staff. The balance study was divided into 2 sessions of 3 weeks each during the summer of 1999 and 2000, with 2 levels of dietary Na+ during each summer. During the summer of 1999 subjects consumed a low calcium diet while in the summer of 2000 subjects consumed a high calcium diet. The Na+ intake periods were separated by a 2-week period, in which subjects were free to consume self-selected diets. Subjects collected fecal and urine daily for 20 days. Other measurements included daily body weight, blood pressure every other day, blood sample at the end of each session. Baseline measures included bone mass, self-assessment of pubertal development, a physical examination and diet history.
- Conditions
- Osteoporosis
- Being tested
- Low Na diet (1.3 g/d), High sodium diet (3.8 g/d)
- Keywords
- calcium retention, sodium retention
- Medical subject headings
- Osteoporosis, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Na diet (1.3 g/d)Other
Also called low sodium, sodium calcium
20 day controlled feeding study (live in) providing 1.3 grams per day of sodium.
High sodium diet (3.8 g/d)Other
Also called high sodium, sodium calcium
20 day controlled feeding study (live in) providing 3.8 grams per day of sodium.
| Study group | Role | What they receive |
|---|---|---|
| High calcium diets (1300 mg or higher) | Experimental | Not described Receives: Other: Low Na diet (1.3 g/d); Other: High sodium diet (3.8 g/d) |
| Low calcium diet (800 mg/d) | Experimental | Not described Receives: Other: Low Na diet (1.3 g/d); Other: High sodium diet (3.8 g/d) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in calcium retention(mg/d)due to high (4g/d) and low (1g/d) sodium intake.
Measured: Up to 12 weeks
Secondary outcomes (3)
Potassium retention in the black and white adolescent subjects
Measured: Up to 12 weeks
Racial differences on the effects of high and low sodium intake levels on calcium intake requirements and calcium retention in adolescent girls
Measured: Up to 12 weeks
Magnesium retention in the black and white adolescent subjects
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startJan 1999
- Primary completionAug 2000
- Study completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Child Health
- Responsible party
- Principal investigator, Berdine Martin, Purdue University
- Investigators
- Connie M Weaver, PhD, Principal investigator, Purdue UniversityBerdine R Martin, PhD, Study director, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564238
- Sponsor's protocol ID
- Camp Calcium 5-6
- Status last verified
- May 2018
- First submitted
- 2 Feb 2012
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Palacios C, Wigertz K, Martin BR, Braun M, Pratt JH, Peacock M, Weaver CM. Racial differences in potassium homeostasis in response to differences in dietary sodium in girls. Am J Clin Nutr. 2010 Mar;91(3):597-603. doi: 10.3945/ajcn.2009.28400. Epub 2009 Dec 9.
PubMed 20007307Thierry-Palmer M, Henderson VM, Hammali RE, Cephas S, Palacios C, Martin BR, Weaver CM. Black and white female adolescents lose vitamin D metabolites into urine. Am J Med Sci. 2008 Apr;335(4):278-83. doi: 10.1097/MAJ.0b013e31815768db.
PubMed 18414066Braun M, Palacios C, Wigertz K, Jackman LA, Bryant RJ, McCabe LD, Martin BR, McCabe GP, Peacock M, Weaver CM. Racial differences in skeletal calcium retention in adolescent girls with varied controlled calcium intakes. Am J Clin Nutr. 2007 Jun;85(6):1657-63. doi: 10.1093/ajcn/85.6.1657.
PubMed 17556706Wigertz K, Palacios C, Jackman LA, Martin BR, McCabe LD, McCabe GP, Peacock M, Pratt JH, Weaver CM. Racial differences in calcium retention in response to dietary salt in adolescent girls. Am J Clin Nutr. 2005 Apr;81(4):845-50. doi: 10.1093/ajcn/81.4.845.
PubMed 15817862Palacios C, Wigertz K, Martin BR, Jackman L, Pratt JH, Peacock M, McCabe G, Weaver CM. Sodium retention in black and white female adolescents in response to salt intake. J Clin Endocrinol Metab. 2004 Apr;89(4):1858-63. doi: 10.1210/jc.2003-031446.
PubMed 15070956Palacios C, Wigertz K, Braun M, Martin BR, McCabe GP, McCabe L, Pratt JH, Peacock M, Weaver CM. Magnesium retention from metabolic-balance studies in female adolescents: impact of race, dietary salt, and calcium. Am J Clin Nutr. 2013 May;97(5):1014-9. doi: 10.3945/ajcn.112.039867. Epub 2013 Apr 3.
PubMed 23553157
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Intake on Calcium Retention in Black and White Adolescent Girls.
- ClinicalTrials.gov ID
- NCT01564238
- Acronym / sponsor ID
- Camp Calcium 5-6
- Conditions
- Osteoporosis
- Keywords
- calcium retention, sodium retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Institute of Child Health
- Study start
- Jan 1999
- Primary completion
- Aug 2000 (actual)
- Study completion
- Aug 2000 (actual)
- First posted
- 27 Mar 2012 (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.
Optimal calcium retention is important for building bone mass within the genetic potential, a key to reducing risk of osteoporosis later in life. Calcium retention is high during the rapid growth period. The investigators know that urinary calcium is affected by sodium intake but the investigators do not know the effects of sodium intake during the growth spurt or the differences in calcium retention between blacks and whites. Our hypothesis was that a high dietary sodium increases the calcium intakes required for optimal calcium retention in both black and white adolescent girls. The investigators tested calcium retention while girls consumed a low and high sodium diet during three week periods. The subjects were housed in a Purdue fraternity house during the summer and they were supervised at all times by trained staff. During the summer of 1999, subjects consumed diets with 2 levels of dietary Na+ with a fixed diet low in calcium. On the next summer, they switched to a high calcium diet. Subjects collected fecal and urine daily for 20 days. Other measurements included daily body weight, blood pressure every other day, blood sample at the end of each session. Baseline measures included bone mass, self-assessment of pubertal development, a physical examination and diet history.
Detailed description
Optimal calcium retention is a prerequisite for building maximal peak bone mass within the genetic potential, a key to reducing risk of osteoporosis later in life. The investigators have determined that maximal calcium retention averages 423 mg/day during the period of rapid skeletal accretion in white girls at a mean dietary calcium intake of 1300 mg/d. Urinary calcium explains more than 50% of the variance in calcium retention. However, urinary sodium (i.e. sodium intake)is a major determinant of urinary calcium excretion and the effect of sodium intake on maximal calcium retention is not known. Nor is its effect known in black adolescents who have higher bone density and lower calcium excretion than white adolescents.
The primary aim was to test the hypothesis that high dietary sodium increases the calcium intakes required for optimal calcium retention in both black and white adolescent girls. Calcium retention was measured at two levels of dietary sodium in a randomized crossover design on one of two levels of dietary calcium intake in black and white adolescent girls during three week metabolic periods. The investigators hypothesized that the mechanisms which regulate sodium reabsorption in the renal tubules also regulate calcium retention. Increased incidence of hypertension in blacks compared to whites has been attributed to increased sodium retention. Sodium intake induced changes in calcium and sodium retention in both races were related to changes in sodium handling (plasma renin activity, serum aldosterone, and salt sensitivity) and calcium regulating hormones, biomarkers of bone turnover and bone mass.
The subjects were resident in a Purdue fraternity house, which was transformed during the summer into a metabolic unit. Subjects were supervised at all times by trained staff. The balance study was divided into 2 sessions of 3 weeks each during the summer of 1999 and 2000, with 2 levels of dietary Na+ during each summer. During the summer of 1999 subjects consumed a low calcium diet while in the summer of 2000 subjects consumed a high calcium diet. The Na+ intake periods were separated by a 2-week period, in which subjects were free to consume self-selected diets. Subjects collected fecal and urine daily for 20 days. Other measurements included daily body weight, blood pressure every other day, blood sample at the end of each session. Baseline measures included bone mass, self-assessment of pubertal development, a physical examination and diet history.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High calcium diets (1300 mg or higher) | Experimental | Other: Low Na diet (1.3 g/d), Other: High sodium diet (3.8 g/d) |
| Low calcium diet (800 mg/d) | Experimental | Other: Low Na diet (1.3 g/d), Other: High sodium diet (3.8 g/d) |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- White or black race (both parents and grandparents had to be white or black to be eligible in the study).
Key exclusion criteria (3 listed)
- < 11 or > 15 years
- body mass index (BMI) of < 15th or > 85th percentile for age
- history of amenorrhea, pregnancy or abortion, eating disorders, oral contraceptive or tobacco use.
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 |
|---|---|---|
| Low Na diet (1.3 g/d)Also: low sodium, sodium calcium20 day controlled feeding study (live in) providing 1.3 grams per day of sodium. | Other | High calcium diets (1300 mg or higher), Low calcium diet (800 mg/d) |
| High sodium diet (3.8 g/d)Also: high sodium, sodium calcium20 day controlled feeding study (live in) providing 3.8 grams per day of sodium. | Other | High calcium diets (1300 mg or higher), Low calcium diet (800 mg/d) |
Primary outcome
Change in calcium retention(mg/d)due to high (4g/d) and low (1g/d) sodium intake.
Time frame: Up to 12 weeks
3 secondary outcomes
Potassium retention in the black and white adolescent subjects
Time frame: Up to 12 weeks
Racial differences on the effects of high and low sodium intake levels on calcium intake requirements and calcium retention in adolescent girls
Time frame: Up to 12 weeks
Magnesium retention in the black and white adolescent subjects
Time frame: Up to 12 weeks
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 9 May 2018.
- Results publication: PubMed 20007307Palacios C, Wigertz K, Martin BR, Braun M, Pratt JH, Peacock M, Weaver CM. Racial differences in potassium homeostasis in response to differences in dietary sodium in girls. Am J Clin Nutr. 2010 Mar;91(3):597-603. doi: 10.3945/ajcn.2009.28400. Epub 2009 Dec 9.
- Results publication: PubMed 18414066Thierry-Palmer M, Henderson VM, Hammali RE, Cephas S, Palacios C, Martin BR, Weaver CM. Black and white female adolescents lose vitamin D metabolites into urine. Am J Med Sci. 2008 Apr;335(4):278-83. doi: 10.1097/MAJ.0b013e31815768db.
- Results publication: PubMed 17556706Braun M, Palacios C, Wigertz K, Jackman LA, Bryant RJ, McCabe LD, Martin BR, McCabe GP, Peacock M, Weaver CM. Racial differences in skeletal calcium retention in adolescent girls with varied controlled calcium intakes. Am J Clin Nutr. 2007 Jun;85(6):1657-63. doi: 10.1093/ajcn/85.6.1657.
- Results publication: PubMed 15817862Wigertz K, Palacios C, Jackman LA, Martin BR, McCabe LD, McCabe GP, Peacock M, Pratt JH, Weaver CM. Racial differences in calcium retention in response to dietary salt in adolescent girls. Am J Clin Nutr. 2005 Apr;81(4):845-50. doi: 10.1093/ajcn/81.4.845.
- Results publication: PubMed 15070956Palacios C, Wigertz K, Martin BR, Jackman L, Pratt JH, Peacock M, McCabe G, Weaver CM. Sodium retention in black and white female adolescents in response to salt intake. J Clin Endocrinol Metab. 2004 Apr;89(4):1858-63. doi: 10.1210/jc.2003-031446.
- Derived from this study: PubMed 23553157Palacios C, Wigertz K, Braun M, Martin BR, McCabe GP, McCabe L, Pratt JH, Peacock M, Weaver CM. Magnesium retention from metabolic-balance studies in female adolescents: impact of race, dietary salt, and calcium. Am J Clin Nutr. 2013 May;97(5):1014-9. doi: 10.3945/ajcn.112.039867. Epub 2013 Apr 3.
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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.
Connie M Weaver, PhD principal investigator
Purdue University
Berdine R Martin, PhD study director
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Na diet (1.3 g/d) and High sodium diet (3.8 g/d) in people with Osteoporosis, run by Purdue University at 1 site in United States.
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 1 inclusion and 3 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 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in calcium retention(mg/d)due to high (4g/d) and low (1g/d) sodium intake. (time frame: Up to 12 weeks). 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 NCT01564238, which also lists 6 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 9 May 2018.