Sponsor study identifier
observational
112
0 countries
N/A
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)There is current interest in the role of vitamin D in the prevention and treatment of many chronic diseases, including osteoporosis, cancer and neurological disease. The majority of vitamin D in the UK comes from the action of sunlight on skin, and very little from dietary sources. Half of the adult United Kingdom (UK) population have vitamin D insufficiency (according to the Institute of Medicine definition). There are still several important unknowns, including what the optimum levels of vitamin D are, and whether the same intake of vitamin D is appropriate for all sections of the population. Low 25(OH)D and high parathyroid hormone (PTH) have been observed in people with high adiposity (obesity), and the summer rise in vitamin D is blunted in obesity. The potential causes of low 25(OH)D levels include an inadequate supply of vitamin D (by reduced sunlight exposure or poor nutrition), the large pool size of adipose tissue or increased metabolic clearance rate. The investigators will measure metabolites of vitamin D and the kinetics of 25(OH)D using stable isotope techniques in lean, overweight and obese men, women and children to establish whether age, gender and obesity affect vitamin D metabolism and clearance rate. If low 25(OH)D in obesity is related to poorer skeletal health and is due to increased clearance of 25(OH)D or large pool size, then total requirements, and hence supplementation requirements, would be larger for obese people than for lean people.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 2013
Actual (reported)April 2013
Actual (reported)December 7, 2015
Actual (reported)December 14, 2015
Actual (reported)difference in serum 25OHD between groups
one measurement at study entry (cross-sectional study)
difference in 25OHD half-life between groups using the stable isotope tracer method
one measurement at study entry (cross-sectional study)
difference in mean sunlight exposure score between groups (questionnaire)
one measurement at study entry (cross-sectional study)
difference in mean dietary vitamin D intake between groups (diet diary)
one measurement at study entry (cross-sectional study)
difference in mean of other serum vitamin D metabolites and measures between groups
one measurement at study entry (cross-sectional study)
Healthy men and women ages 25-40 and 55-75. BMI 18.5 to 25.0
Healthy men and women ages 25-40 and 55-75. BMI 25.0 to 30.0
Healthy men and women ages 25-40 and 55-75. BMI over 30
The total study sample will consist of 136 participants (112 adults and 24 children) who are lean, overweight or obese. Participants will be drawn from two previous studies; 'The effects of obesity on bone structure and strength' (STH 15688) and 'Body weight and bone' (STH16199), in which their body composition, bone strength and biochemistry have been documented in detail. All participants from the previous studies will be invited to participate, and recruitment will continue until 112 adults and 24 children across a range of body weights have been recruited.
serum, plasma, urine, DNA
Jennifer S Walsh, MBChB PhD
University of Sheffield
112 participants (actual enrollment reported by the registry).
First Submitted
December 7, 2015
First Posted
December 14, 2015
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Soy, Bone and Health in College Females
Contact the study team to confirm eligibility.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
December 14, 2015
Record last verified: 2015-12
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Source: ClinicalTrials.gov.
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