Protocol Title: 25-hydroxyvitamin D [25(OH)D] serum levels and associated health outcomes in the population resulting from a program of education and testing The purpose of this population study is to offer testing and/or feedback about results and education to make necessary lifestyle changes to effect serum level concentrations. In this study you will create an account with GrassrootsHealth (GRH), fill out a health questionnaire and receive vitamin D test results either from a home blood spot test provided by GRH or from a participating GRH Certified physician and lab (available only to participants of qualifying GRH projects). For the home blood spot test, you will provide drops of blood on the blood spot card and return it to GRH. The results of the test will be made available to you through the account created on the GRH website along with information about target levels. The test results are strictly informational. The review of your test results by the study investigator does not represent diagnosis and treatment.
The health questionnaire will be filled out and testing will occur at regular intervals. It is an international study which is expected to involve over 100,000 participants. You may not receive a direct benefit if you agree to participate. However, people in the future may benefit from the information obtained from this research. There is minimal risk to obtaining blood drops for testing 25(OH)D. The test generally will be done in your home, using a sterile self-loaded lancet to puncture the fingertip. This will be done after a thorough washing of hands with soap and warm water and the use of an alcohol swab where the blood drops will be obtained. We are aware of no reports of harm other than short term pain with using the test. You are advised that if any complications develop you should consult your healthcare provider. You will be advised if there is any new information that would influence your decision about participation. Your alternative to participating in this study includes requesting your own physician to order the 25(OH)D test .
Results from physician ordered tests can only be used by participants of a qualifying GRH project and if the physician and lab are contracted with GRH. You can use the free educational pieces on the website without participating in the study. Contact Jen Aliano at (760) 710-9305 for questions about the research or if you think you have been harmed as a result of joining this research. Contact the Western Institutional Review Board (WIRB) if you have questions about your rights as a research subject: 1-800-562-4789. WIRB is a group of people who perform independent review of research. If you use certain electronic health applications (apps), you may opt to have data from that application securely shared with GrassrootsHealth. Third-party data, such as that from the health application, is de-identified and transmitted with a unique identification code that will link health data from each application with information in your GrassrootsHealth account, and will allow for expanded analysis.
Your individual health data will be kept confidential except for where required by law. The accumulated data will be stored in a secured, encrypted database operating behind a firewall, and password protected. The only person that will have access to the identified data will be our primary data biostatistician. This will be for purposes of accessing hospital records as indicated and released by participants, or for clarification of entries in the health questionnaire. The de-identified health information is shared so the research can be conducted, properly monitored and published. The Principal Investigator and other researchers will access the data in a de-identified form. For all analyses only an arbitrary number will identify the participant. If you are under 18 years of age, parental consent must be provided to participate in this study. This permission will not end unless you cancel it. You may cancel it by sending written notice to the study leader at: GrassrootsHealth, 315 S Coast Hwy 101, Suite U-87, Encinitas, CA 92024.
Your decision to be in this study is voluntary. You will not be penalized or lose benefits if you decide not to participate or if you decide to stop participating. There may be a sponsorship fee associated with participation in this study. Sponsorship supports the efforts of documenting serum levels and health outcomes, feedback of the information, as well as the tests and laboratory fees. This is a Home Test Kit. The idea is that this will be done independently of my office and is for patients' own information. City Assays offer a home test kit for Vitamin D using dried blood spot technology. The work is performed in their NHS Vitamin D laboratory - this laboratory also offers a national Vitamin D service for the NHS in the United Kingdom. Liquid chromatography mass spectrometry is used to measure the Vitamin D in your blood. Measurements of Vitamin D2 and D3 are made and City Assays report the Total and D2 and D3 results with their own interpretation. Request a collection kit by phone using a debit or credit card at the time you order
Kits are sent to you by first class post or Airmail Follow the simple instructions and send back using the pre-paid envelope supplied (overseas users need to affix air mail postage) City Assays aim to send you results within 5 working days from the time they receive your sample You receive results as a pdf attached to an email with City Assay's own interpretation Orders for kits after 1st July 2014: £28 to UK/Ireland, Overseas (please contact the office) Further details can be found here - City Assays webpage on Vitamin D Home Test Kit Your very good health! Test results and what they mean Allergies, autoimmunity and infections Heart disease and circulation Joints, muscles and bones Nutrition, vitamins, minerals and diets Toxic problems: pollution and poisonings Women's health, fertility and healthy babiesOne third of UK adults spend less than an hour per day outdoors, according to new research conducted ahead of National Vitamin D Awareness Week (19th – 25th October).
Our 'indoor' lifestyle and lack of British sunshine is placing millions of Brits at risk of vitamin D deficiency, warns ITV's Dr. Chris Steele. A further 50% of the 650 people surveyed in the Pharma Nord consumer poll spend less than 2 hours per day outdoors, while just 5% spend more than four hours outside. The majority of our vitamin D requirement – around 90 per cent – must be created in the skin in response to strong sunlight. Up to 50% of UK adults are thought to be deficient in this vital 'sunshine' vitamin, with the highest rates of deficiency in Northern England, Scotland and Northern Ireland due to limited sun exposure. Vitamin D deficiency costs the UK taxpayer £29 billion annually – more than a quarter of the NHS budget. Despite the prevalence of deficiency, three quarters of UK adults admit that they have never had a vitamin D test, either through a GP or a self-test. The importance of vitamin DLow levels of vitamin D have been linked to seasonal affective disorder (SAD), a type of depression that comes and goes in a seasonal pattern, with symptoms often more apparent and severe during winter.
A lack of vitamin D is also associated with poor immune health, susceptibility to colds and flu and tiredness and fatigue. The new survey from Pharma Nord, developers of Bio-Vitamin D3, has revealed that: Commenting on the research, Dr Chris Steele, medical doctor and ITV This Morning's resident GP said: “There needs to be greater awareness of the risk of vitamin D deficiency in the UK. While all of us could be affected, the higher risk groups include those aged over 65, pregnant and breastfeeding women, ethnic minorities, children and people who spend large amounts of time indoors. "I would urge all UK adults, and particularly people in these groups, to discuss with their GP a vitamin D test and the taking of a high quality vitamin D supplement. There is often confusion over the best form of vitamin D to take, so look for vitamin D3 as this form is identical to the kind produced naturally in the skin. Also oil-based capsules can be more easily absorbed by the body compared to dry, chalky tablets."