OsteoporosisNCT02629198
The Effect of Body Weight on Vitamin D Metabolism
An observational study of Osteoporosis and Obesity, run by Sheffield Teaching Hospitals NHS Foundation Trust.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Obesity
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 77 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Caucasian
- BMI of 18.5 kg/m2 or above for adults, 2nd-91st centile or above 98th centile for children
- Ages 8 to 15 (children), 16 to 42 years (and premenopausal if female) or 55 to 77 years (and postmenopausal (at least 5 years since last menstrual period (LMP) if female)
- Able and willing to participate in the study and provide written informed consent Completed either STH15688 or STH16199 and gave consent to be approached about future studies
Who cannot join
- History of any long term immobilization (duration greater than three months)
- Current confirmed or possible pregnancy (urinary pregnancy test if LMP >28 days)
- Previously-diagnosed diabetes mellitus
- History of or current conditions known to affect bone metabolism, including
- Diagnosed skeletal disease
- Chronic renal disease
Show all 14Show fewer
- Malabsorption syndromes
- Diagnosed endocrine disorders
- Hypocalcemia or hypercalcemia
- Diagnosed restrictive eating disorder Use of medications or treatment known to affect bone metabolism, including
- Depot medroxyprogesterone or the combined oral contraceptive pill
- Alcohol intake of greater than 21 units per week
- Competitive athlete, defined as participating in competitive sport at amateur or professional level
- Holiday with significant sunlight exposure in the last six weeks
About this study
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.
Read more
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.
Read the detailed description
Part 1: Measurement of vitamin D and metabolites (adults and children) Circulating levels of vitamin D metabolites are influenced by calcium intake, so participants will be asked to complete a seven day diet diary before the first vitamin D measurement. Measured vitamin D is influenced by vitamin D binding protein, lipids and inflammatory cytokines, so the investigators will include and correct for these measurements.
Visit 1 Consent Height and weight Diet diary instructions Urine collection instructions
Visit 2 Return of 24h urine collection for calcium and creatinine Return of diet diary Fasting blood sample for vitamin D, binding protein and metabolites C reactive protein (CRP), lipids and creatine kinase (CK), PTH, insulin-like growth factor -1 (IGF-1), creatinine, calcium, albumin, phosphate
Part 2: Measurement of vitamin D clearance rate (adults only) Kinetic studies will be perturbed by acute changes in vitamin D (most likely to be caused by sunlight exposure on a sunny day), and so the studies will all be conducted in the autumn, winter, and early spring when sunlight in Sheffield will not be strong enough to deliver large doses of vitamin D.
The administration and sampling protocol for the kinetics study has been developed by statisticians at the Sheffield School of Health and Related Research (ScHaRR) in collaboration with the Medical Research Council Human Nutrition Unit, based on modelling from their previous use of the stable isotope tracer method.
Visit 2 Oral administration of stable vitamin D isotope
Visit 3 (5-7 days after visit 2) Blood sample for tracer and vitamin D metabolites
Visit 4 (9 days ± 2 after visit 2) Blood sample for tracer and vitamin D metabolites
Visit 5 (27 days ± 2 after visit 2) Blood sample for tracer and vitamin D metabolites
Visit 6 (30 days ± 2 after visit 2) Blood sample for tracer and vitamin D metabolites Height and weight
The effect of obesity on vitamin D metabolites will be determined by regression models of BMI and vitamin D measurements corrected for age and gender.
The effects of obesity on vitamin D kinetics will be determined by modelling metabolic clearance rate on age, gender and BMI.
Subjects' previous data from the 'Effects of obesity on bone structure and strength'study (STH 15688) and the 'Body weight and bone' study (STH16199) will be used to evaluate relationships between vitamin D metabolism and body fat distribution, bone density and structure, and bone biochemistry.
- Conditions
- Osteoporosis, Obesity
- Keywords
- Vitamin D
- Medical subject headings
- Osteoporosis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal weight | Healthy men and women ages 25-40 and 55-75. BMI 18.5 to 25.0 | |
| overweight | Healthy men and women ages 25-40 and 55-75. BMI 25.0 to 30.0 | |
| obese | Healthy men and women ages 25-40 and 55-75. BMI over 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in serum 25OHD between groups
Measured: one measurement at study entry (cross-sectional study)
Secondary outcomes (4)
difference in 25OHD half-life between groups using the stable isotope tracer method
stable isotope tracer method
Measured: one measurement at study entry (cross-sectional study)
difference in mean sunlight exposure score between groups (questionnaire)
annual and summer sunlight score from questionnaire
Measured: one measurement at study entry (cross-sectional study)
difference in mean dietary vitamin D intake between groups (diet diary)
habitual daily vitamin D dietary intake from diet diary
Measured: one measurement at study entry (cross-sectional study)
difference in mean of other serum vitamin D metabolites and measures between groups
free 25OHD, 1,25OHD, vitamin D binding protein (DBP)
Measured: one measurement at study entry (cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, United Kingdom, University of Sheffield, MRC Human Nutrition Research
- Responsible party
- Sponsor
- Investigators
- Jennifer S Walsh, MBChB PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629198
- Sponsor's protocol ID
- STH16353
- Status last verified
- Dec 2015
- First submitted
- 7 Dec 2015
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Weight on Vitamin D Metabolism
- ClinicalTrials.gov ID
- NCT02629198
- Acronym / sponsor ID
- STH16353
- Conditions
- Osteoporosis, Obesity
- Keywords
- Vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Department of Health, United Kingdom, University of Sheffield, MRC Human Nutrition Research
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Part 1: Measurement of vitamin D and metabolites (adults and children) Circulating levels of vitamin D metabolites are influenced by calcium intake, so participants will be asked to complete a seven day diet diary before the first vitamin D measurement. Measured vitamin D is influenced by vitamin D binding protein, lipids and inflammatory cytokines, so the investigators will include and correct for these measurements.
Visit 1 Consent Height and weight Diet diary instructions Urine collection instructions
Visit 2 Return of 24h urine collection for calcium and creatinine Return of diet diary Fasting blood sample for vitamin D, binding protein and metabolites C reactive protein (CRP), lipids and creatine kinase (CK), PTH, insulin-like growth factor -1 (IGF-1), creatinine, calcium, albumin, phosphate
Part 2: Measurement of vitamin D clearance rate (adults only) Kinetic studies will be perturbed by acute changes in vitamin D (most likely to be caused by sunlight exposure on a sunny day), and so the studies will all be conducted in the autumn, winter, and early spring when sunlight in Sheffield will not be strong enough to deliver large doses of vitamin D.
The administration and sampling protocol for the kinetics study has been developed by statisticians at the Sheffield School of Health and Related Research (ScHaRR) in collaboration with the Medical Research Council Human Nutrition Unit, based on modelling from their previous use of the stable isotope tracer method.
Visit 2 Oral administration of stable vitamin D isotope
Visit 3 (5-7 days after visit 2) Blood sample for tracer and vitamin D metabolites
Visit 4 (9 days ± 2 after visit 2) Blood sample for tracer and vitamin D metabolites
Visit 5 (27 days ± 2 after visit 2) Blood sample for tracer and vitamin D metabolites
Visit 6 (30 days ± 2 after visit 2) Blood sample for tracer and vitamin D metabolites Height and weight
The effect of obesity on vitamin D metabolites will be determined by regression models of BMI and vitamin D measurements corrected for age and gender.
The effects of obesity on vitamin D kinetics will be determined by modelling metabolic clearance rate on age, gender and BMI.
Subjects' previous data from the 'Effects of obesity on bone structure and strength'study (STH 15688) and the 'Body weight and bone' study (STH16199) will be used to evaluate relationships between vitamin D metabolism and body fat distribution, bone density and structure, and bone biochemistry.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal weight | – | –Healthy men and women ages 25-40 and 55-75. BMI 18.5 to 25.0 |
| overweight | – | –Healthy men and women ages 25-40 and 55-75. BMI 25.0 to 30.0 |
| obese | – | –Healthy men and women ages 25-40 and 55-75. BMI over 30 |
Who may qualify
- Ages
- 8 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Caucasian
- BMI of 18.5 kg/m2 or above for adults, 2nd-91st centile or above 98th centile for children
- Ages 8 to 15 (children), 16 to 42 years (and premenopausal if female) or 55 to 77 years (and postmenopausal (at least 5 years since last menstrual period (LMP) if female)
- Able and willing to participate in the study and provide written informed consent Completed either STH15688 or STH16199 and gave consent to be approached about future studies
Key exclusion criteria (14 listed)
- History of any long term immobilization (duration greater than three months)
- Current confirmed or possible pregnancy (urinary pregnancy test if LMP >28 days)
- Previously-diagnosed diabetes mellitus
- History of or current conditions known to affect bone metabolism, including
- Diagnosed skeletal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
difference in serum 25OHD between groups
Time frame: one measurement at study entry (cross-sectional study)
4 secondary outcomes
difference in 25OHD half-life between groups using the stable isotope tracer method
Time frame: one measurement at study entry (cross-sectional study)
difference in mean sunlight exposure score between groups (questionnaire)
Time frame: one measurement at study entry (cross-sectional study)
difference in mean dietary vitamin D intake between groups (diet diary)
Time frame: one measurement at study entry (cross-sectional study)
difference in mean of other serum vitamin D metabolites and measures between groups
Time frame: one measurement at study entry (cross-sectional study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer S Walsh, MBChB PhD principal investigator
University of Sheffield
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Obesity, run by Sheffield Teaching Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in serum 25OHD between groups (time frame: one measurement at study entry (cross-sectional study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.