A Comparative Effectiveness Research Study Comparing Changes in Body Composition and Parent Ratings of Quality of Life in 5-19 Year Olds as a Function of Participation in One of Four Versions of the Good NEWS 4 Kids Program (GN4K)
Sponsor study identifier
interventional
200
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study will compare changes in body composition (lean mass, fat, and bone)and parent ratings of quality of life in 5-19 Year Olds as a function of participation in one of four versions of the Good NEWS 4 Kids Program (GN4K).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 8, 2013
Actual (reported)May 16, 2013
Actual (reported)December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change from baseline in parental ratings of participating child's quality of life
Parent(s) will complete questionnaires on a monthly basis to assess the improvements made or improvements that have been made in various areas of their child's behavior and activities. Change from baseline to end of study will be reported.
0 and 90 days
Changes in body composition as a measurement of Dual Energy Absorptiometry
0 and 90 days
Changes in hip to waist ratios
0 and 90 days
Subjects will take 4 MannaBears daily
Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily
Subjects will be administered 4 MannaBears daily
Subjects will be administered 750 mg AlgaeCal Calcium
Integrative Health Technologies
San Antonio, Texas, 78209, United States
Gilbert R Kaats, PhD FACN
Integrative Health Technologies, Inc.
Harry G Preuss, MD MACN
Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
First Submitted
May 8, 2013
First Posted
May 16, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Vitamin D, Cardiovascular Disease, and African Americans
Changes in blood pressure
0 and 90 days
Changes in gender and age adjusted BMI
0 and 90 days
Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily
Subjects will be administered 1000 mg calcium carbonate
Subjects will be administered 800 IU vitamin D3
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 24, 2013
Record last verified: 2013-06
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Source: ClinicalTrials.gov.
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