Done, Doing, Need to do

This week, I held my prospectus meeting. My comittee members were in attendance and we really started to grind out the details of the study. Some of the feedback I received that will really help:

• No placebo, the subjects will serve as their own control group comparing pre-study data with post-study data.
• This will give me the chance to have larger groups when divided into physical activity levels
• Find a nutraceutical company to donate the supplements in exchange for their name on the study
• Lots of feedback on how to create the food/exercise/sun exposure frequency questionnaire
• Question a pharmacist about possible drug interactions
• Transport the equipment to the senior centers to do the scans
• Provide "free blood pressure checks" as an added incentive
• If possible, sub-divide the exercise groups by type of exercise (weight-bearing vs non-weight-bearing)

My priorities are:

• Complete the IRB application
• Complete the literature review
• Request the donation of supplements from Nutraceutical Corp., Ogden, Utah
• Contact local senior centers to request volunteers

I have completed:

• IRB Application sans study description--I wanted to get feedback on the rest as I continued to work on the description
• Requested donation of supplements--Nutraceutical Corp. lab manager works at Weber State and will ask the operations manager after I get him a copy of the study description (another reason I want to spend some time on it)
• Started recruiting volunteers among neighbors and friends.--I mentioned my study to a neighbor and she began to list friends of hers who will also like to participate. 30 subjects should be fairly easy to come by, the concern I have will be screening the subject.

I am working on:

• Lit review!
• Study description for IRB and Nutraceutical Corp

Next on the agenda:

• Complete improved consent form
• Create a food and exercise frequency questionnaire to screen volunteers
• Get that Lit review done!
• Office of Undergraduate Research (OUR) Grant application

I hope to start the study in November. Donated supplements will really help it to get going. Please give me feedback if you know of any concerns i should consider. Thanks!

Equipment accuracy

I had my own bone density scanned on the densitometer that I plan to use for my study. My scan reported that my bones are not very dense at all. My T-score was -1.1. Osteoporosis risk could begin at -1.6. For a 30-year-old woman, this is REALLY BAD. So, I have two problems: either my bones are very weak for someone my age and I need to do something about it, or the equipment that I'm planning to use is not very accurate. I plan to get a more complete DXA scan to test the density of my hip and spine, but in the meantime, I decided to do some research on the accuracy of calcaneal bone densitometers. I found this website: Evaluation of calcaneous bone densitometry against hip and spine for diagnosis of osteoporosis. The study concluded that the equipment is specific--meaning it gives consistent results--which would be the most important factor for research. (comparing pre- and post-study data) but it ultimately concluded that it is best for use in high-risk and low-risk populations because of the cost and availability of a confirming DXA scan. So, I suppose I can conclude that my best hope is to get a follow-up DXA scan and hope for a false heel reading. At least I know that any changes in my readings will be something I can count on for the research.

I also did some searches on the type and dosage of Vitamin D to use. I suppose it will be best to use Vitamin D3 cholecalciferol. D3 is a nutritional supplement although it is not the "active" form of the vitamin (calcitriol). The active form requires a prescription. However, I feel D3 will be great because of the effect it has on overall health. The body's negative feedback mechanism to prevent toxicity respond to levels of calcidiol in the blood (1 step away from calcitriol). Additional calcidiol can be used by the tissues to form a different kind of calcitriol that has other benefits. It is harder to have a toxic level of this compound. I found information on the physiology of Vitamin D on the Vitamin D research website.

Weeks 2 and 3

Last Friday, I met with Rod and we outlined the project. I will be conducting a 2 x 2 pre/post study design to explore the effect that short-term vitamin D supplementation will have on the calcaneal bone mineral density of elderly women with osteoporosis risk. I am excited about this study because it may be new enough information that the entire nutrition community will find it helpful. I will coduct the research on about 24 participants. The bone density scanner is non-invasive and very simple to use. I will be gathering pre-study data, then providing a vitamin supplement or placebo. I will compare the post-study bone density scans with the pre-study scans to see if there is a significant difference. This semester, I will be focusing on preparing all of my preliminary documentation. I started my IRB approval application today. This approval is imperative before I begin research. I will also be doing a literature review, preparing pre-study surveys/questionnaires, and applying for a study grant.

This week, I also scheduled my prospectus meeting. I will be holding it on Tuesday, September 23. After this meeting, all capstone committee members will be on the same page and I will be able to really sink my teeth into the research.

Another instructor gave me an excellent Vitamin D resource today. The Vitamin D Council website has links to a lot of current research. I am looking forward to proceding with this study!

I"m certified!

I just completed the National Institute of Health (NIH) training for Protecting Human Subject Research Participants. I am now certified to conduct research using human subjects. Next step is to complete my IRB application and get approved to do the research. I will also need to schedule my prospectus meeting.