SOLICITATION NOTICE
B -- Health Consequences of Vitamin D Deficiency in Older Adults in the InChianti Study
- Notice Date
- 7/1/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Aging, IRP, BRC, 251 Bayview Blvd, Room 04C009, Baltimore, Maryland, 21224
- ZIP Code
- 21224
- Solicitation Number
- CRBSA08002
- Response Due
- 7/10/2008
- Archive Date
- 7/25/2008
- Point of Contact
- Patricia L Meise, Phone: 410-558-8043
- E-Mail Address
-
meisep@mail.nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Institute on Aging, IRP, Clinical Research Branch located at Harbor Hospital intends to negotiate and award a purchase order on a noncompetitive basis with the Boston University School of Medicine, Boston, MA to undertake clinical research to assess the distribution of vitamin D levels in the InChianti cohort and to determine the health consequences of vitamin D deficiency. The title of this project is “Health Consequences of Vitamin D Deficiency in Older Adults in the InChianti Study”. This project aims to generate population–based healthy reference range for vitamin D levels in community-dwelling older individuals who are participating in the InChianti Study. We will measure vitamin D levels using LC-MS/MS, widely considered the gold standard for the measurement of vitamin levels. We will first evaluate the statistical distribution of vitamin D levels in the InChianti population. Using Lowess plots, we will evaluate the relationship of vitamin D levels with PTH and define vitamin D deficiency in terms of the threshold or the inflection point at which the PTH levels rise above the upper limit of normal. We will then examine the cross-sectional association of outcomes (bone mineral density, walking speed, SPPB scores, muscle strength, disability, hypertension, diabetes mellitus, cardiovascular disease, and other co-morbid conditions) with varying degree of deviations in vitamin D levels from the reference limit. Based on these analyses, we will generate an initial proposal for “healthy range” for vitamin D levels for further validation in additional analyses. The study will require Institutional Review Board approval at both Boston University and the National Institute on Aging. Because these analyses will utilize existing serum and data that have already been collected, they impose no additional burden on the subjects and require no further contact with the participants. The amount of serum required for these analyses is small (100ul). The contractor will perform the following: 1) measure vitamin D levels in 1000 individuals in the InChianti study (approximately 500 men and 500 women) using LC-MS/MS based assay; 2) analyze the data, in collaboration with Drs. Guralnik and Ferrucci and their staff, on the distribution of vitamin D levels and the cross-sectional association of deviations of vitamin D levels with outcomes in the InChianti study; 3) generate preliminary proposal for “healthy vitamin range”. The contractor shall provide the assay method for the study. The contractor will also develop and report plans for quality control and data entry. The main deliverables are the assay results and the analytical plans for the utilization of these results. Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C. 253 (c) (1), FAR 6.302-1 (b) (1). The cited authority is applicable because the Boston University School of Medicine, Boston Medical Center is internationally recognized in endocrinology with expertise in androgen biology, especially hormone assays. They have experience that is critical for developing standardized assays for steroid hormone measurements and have a state-of-art laboratory with scientific and instrumental infrastructure to perform the vitamin D assays. Boston Medical Center has previously led NIH-funded efforts to develop and standardize LC-MS/MS assays for testosterone and estradiol; as such, is the PI of an NIA-funded grant to generate population-based reference ranges for testosterone. Over the last few years, Boston Medical Center has developed unique experience and insight in the specific assay methodology used in this project which allow a continuous supervision and quality control of the data generated that are crucial to the success of this project. While the same assay could be implemented by other research groups, this would require extensive testing and validation before they become acceptable (this extensive testing would also require more sample volume which is in very limited supply), and, as a consequence, the cost of this project would become substantially higher. This acquisition is being conducted under Simplified Acquisition procedures and is exempt form the requirements of FAR, Part 6, Competition Requirement. Award will be made on an all or none basis to the lowest price, technically acceptable source.
- Web Link
-
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(https://www.fbo.gov/?s=opportunity&mode=form&id=45355ceee54d495ea1bd429127bdef2b&tab=core&_cview=1)
- Place of Performance
- Address: 670 Albany Street, Boston, Massachusetts, 02118, United States
- Zip Code: 02118
- Zip Code: 02118
- Record
- SN01605673-W 20080703/080701223254-45355ceee54d495ea1bd429127bdef2b (fbodaily.com)
- Source
-
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