- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01564238
Effect of Sodium Intake on Calcium Retention in Girls
Effect of Sodium Intake on Calcium Retention in Black and White Adolescent Girls.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
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West Lafayette, Indiana, United States, 47906
- Purdue University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- White or black race (both parents and grandparents had to be white or black to be eligible in the study).
Exclusion Criteria:
- < 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High calcium diets (1300 mg or higher)
|
20 day controlled feeding study (live in) providing 1.3 grams per day of sodium.
Other Names:
20 day controlled feeding study (live in) providing 3.8 grams per day of sodium.
Other Names:
|
Experimental: Low calcium diet (800 mg/d)
|
20 day controlled feeding study (live in) providing 1.3 grams per day of sodium.
Other Names:
20 day controlled feeding study (live in) providing 3.8 grams per day of sodium.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in calcium retention(mg/d)due to high (4g/d) and low (1g/d) sodium intake.
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Potassium retention in the black and white adolescent subjects
Time Frame: Up to 12 weeks
|
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
|
Up to 12 weeks
|
Magnesium retention in the black and white adolescent subjects
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Berdine R Martin, PhD, Purdue University
Publications and helpful links
General 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.
- Thierry-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.
- Braun 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.
- Wigertz 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.
- Palacios 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.
- Palacios 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Camp Calcium 5-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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