Effect of Sodium Intake on Calcium Retention in Girls
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Na diet (1.3 g/d)
High sodium diet (3.8 g/d)
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring calcium retention, sodium retention
Eligibility Criteria
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.
Sites / Locations
- Purdue University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High calcium diets (1300 mg or higher)
Low calcium diet (800 mg/d)
Arm Description
Outcomes
Primary Outcome Measures
Change in calcium retention(mg/d)due to high (4g/d) and low (1g/d) sodium intake.
Secondary Outcome Measures
Potassium retention in the black and white adolescent subjects
Racial differences on the effects of high and low sodium intake levels on calcium intake requirements and calcium retention in adolescent girls
Magnesium retention in the black and white adolescent subjects
Full Information
NCT ID
NCT01564238
First Posted
February 2, 2012
Last Updated
May 3, 2018
Sponsor
Purdue University
Collaborators
Institute of Child Health
1. Study Identification
Unique Protocol Identification Number
NCT01564238
Brief Title
Effect of Sodium Intake on Calcium Retention in Girls
Official Title
Effect of Sodium Intake on Calcium Retention in Black and White Adolescent Girls.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
August 2000 (Actual)
Study Completion Date
August 2000 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Institute of Child Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
calcium retention, sodium retention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High calcium diets (1300 mg or higher)
Arm Type
Experimental
Arm Title
Low calcium diet (800 mg/d)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Low Na diet (1.3 g/d)
Other Intervention Name(s)
low sodium, sodium calcium
Intervention Description
20 day controlled feeding study (live in) providing 1.3 grams per day of sodium.
Intervention Type
Other
Intervention Name(s)
High sodium diet (3.8 g/d)
Other Intervention Name(s)
high sodium, sodium calcium
Intervention Description
20 day controlled feeding study (live in) providing 3.8 grams per day of sodium.
Primary Outcome Measure Information:
Title
Change in calcium retention(mg/d)due to high (4g/d) and low (1g/d) sodium intake.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Potassium retention in the black and white adolescent subjects
Time Frame
Up to 12 weeks
Title
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
Title
Magnesium retention in the black and white adolescent subjects
Time Frame
Up to 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie M Weaver, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berdine R Martin, PhD
Organizational Affiliation
Purdue University
Official's Role
Study Director
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20007307
Citation
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.
Results Reference
result
PubMed Identifier
18414066
Citation
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.
Results Reference
result
PubMed Identifier
17556706
Citation
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.
Results Reference
result
PubMed Identifier
15817862
Citation
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.
Results Reference
result
PubMed Identifier
15070956
Citation
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.
Results Reference
result
PubMed Identifier
23553157
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Sodium Intake on Calcium Retention in Girls
We'll reach out to this number within 24 hrs