NCT01564238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2000

Completed
11.5 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

February 2, 2012

Last Update Submit

May 3, 2018

Conditions

Osteoporosis

Keywords

calcium retentionsodium retention

Outcome Measures

Primary Outcomes (1)

  • Change in calcium retention(mg/d)due to high (4g/d) and low (1g/d) sodium intake.

    Up to 12 weeks

Secondary Outcomes (3)

  • Potassium retention in the black and white adolescent subjects

    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

    Up to 12 weeks

  • Magnesium retention in the black and white adolescent subjects

    Up to 12 weeks

Study Arms (2)

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)

Interventions

Low Na diet (1.3 g/d)OTHER

20 day controlled feeding study (live in) providing 1.3 grams per day of sodium.

Also known as: low sodium, sodium calcium
High calcium diets (1300 mg or higher)Low calcium diet (800 mg/d)
High sodium diet (3.8 g/d)OTHER

20 day controlled feeding study (live in) providing 3.8 grams per day of sodium.

Also known as: high sodium, sodium calcium
High calcium diets (1300 mg or higher)Low calcium diet (800 mg/d)

Eligibility Criteria

Age11 Years - 15 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • White or black race (both parents and grandparents had to be white or black to be eligible in the study).

You may not qualify if:

  • \< 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

Related Publications (6)

  • 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.

    PMID: 20007307RESULT

  • 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.

    PMID: 18414066RESULT

  • 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.

    PMID: 17556706RESULT

  • 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.

    PMID: 15817862RESULT

  • 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.

    PMID: 15070956RESULT

  • 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.

    PMID: 23553157DERIVED

MeSH Terms

Conditions

OsteoporosisHypernatremia

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Connie M Weaver, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

  • Berdine R Martin, PhD

    Purdue University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist, Nutrition Science

Study Record Dates

First Submitted

February 2, 2012

First Posted

March 27, 2012

Study Start

January 1, 1999

Primary Completion

August 1, 2000

Study Completion

August 1, 2000

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

US(1)