Opportunity Information: Apply for RFA AG 14 001
Apply for RFA AG 14 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Dose Response and Efficacy Studies on the Effects of Vitamin D Supplementation on Functional Outcomes in Elderly (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866 Aging Research.
- This funding opportunity was created on Jul 8, 2013 and posted on Jul 8, 2013.
- Applicants must submit their applications by Sep 23, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Independent school districts Private institutions of higher education City or township governments Special district governments County governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) State governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The National Institute on Aging (NIA) offered this funding opportunity (RFA AG-14-001) to support a large, well-powered clinical trial testing whether vitamin D supplementation can prevent falls in older adults and improve or preserve physical function, with gait speed identified as a key secondary outcome. The central aim is not just to ask whether vitamin D helps, but to map out a clear dose-response relationship across multiple supplement doses and across different baseline vitamin D levels. In practical terms, the project is expected to determine which doses are most effective, for which groups of older individuals (for example, those starting with low versus adequate vitamin D status), and whether any observed benefits extend beyond falls to measurable changes in mobility.
The award mechanism is a U01 cooperative agreement, which means the project would be carried out with substantial NIH scientific involvement rather than as a fully investigator-driven grant. The expectation is a six-year effort in which the funded team designs and executes a randomized controlled trial with enough statistical power to detect meaningful differences in fall outcomes between dose groups. NIA specifically encouraged applicants to use advanced, cost-efficient trial designs, particularly designs that begin with a dose-ranging phase and then transition into an efficacy phase focused on the most promising dose levels. Adaptive approaches were highlighted as examples, reflecting an interest in modern designs that can conserve resources while still generating strong causal evidence.
A notable feature is the structured start-up period: the first nine months of the award were set aside for pilot and planning work rather than immediate full-scale enrollment. During this period, the awardee would test recruitment strategies, quantify how many screened individuals are actually eligible and willing to be randomized, and finalize the full protocol. That includes producing the study’s data collection forms and a detailed manual of procedures, which are essential for standardizing operations across sites and ensuring consistent outcome measurement, participant follow-up, and safety monitoring. This front-loaded pilot phase signals that NIA wanted applicants to de-risk the trial early by demonstrating feasible recruitment and clear, implementable procedures before committing to full implementation.
In terms of what the trial should measure, falls are the primary clinical endpoint, with gait speed proposed as a secondary functional endpoint. Falls are a major driver of disability, hospitalization, and loss of independence in older adults, so a prevention effect would have substantial public health relevance. Gait speed is widely used as a meaningful indicator of mobility and overall functional status in aging research; including it as an outcome helps clarify whether vitamin D’s impact (if any) is limited to falls or also reflects broader functional changes. The announcement also makes clear that baseline vitamin D status matters scientifically, so the trial is expected to consider how starting levels of vitamin D influence response to supplementation, rather than treating the older population as a single uniform group.
Administratively, this opportunity was categorized as discretionary funding, under the NIH activity category of health (CFDA 93.866, Aging Research), and it did not require cost sharing or matching. Eligible applicants were broad and included many types of U.S.-based organizations such as higher education institutions (public and private), nonprofit and for-profit organizations, small businesses, state and local governments, tribal governments and organizations, school districts, and various community-based or faith-based organizations. The eligibility list also explicitly included several categories of minority-serving institutions (such as HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, Alaska Native and Native Hawaiian serving institutions) and U.S. territories or possessions. Foreign institutions and non-U.S. components of U.S. organizations were not eligible, and foreign components were not allowed under NIH policy for this announcement.
The announcement was posted on July 8, 2013, with an original and current closing date of September 23, 2013, and it was archived on October 24, 2013. While the solicitation itself is no longer open, the structure of the opportunity is clear: NIA sought a rigorously designed randomized trial that could answer dose-response questions about vitamin D supplementation in older adults, establish efficacy for fall prevention, and provide secondary evidence related to gait speed and functional outcomes, with an initial pilot phase to validate feasibility and finalize trial operations before full-scale execution.
FAQs: NIA Funding Opportunity RFA AG-14-001 (Vitamin D and Falls in Older Adults)
What is the purpose of this funding opportunity?
The National Institute on Aging (NIA) funding opportunity RFA AG-14-001 was intended to support a large, well-powered randomized clinical trial to test whether vitamin D supplementation can prevent falls in older adults and improve or preserve physical function.
What is the main research question the trial is expected to answer?
The central question is whether vitamin D supplementation reduces falls in older adults. In addition, the trial is expected to go beyond a simple yes/no answer by mapping a clear dose-response relationship across multiple vitamin D doses and across different baseline vitamin D levels.
Why is dose-response a major focus of the trial?
NIA emphasized determining how outcomes change across different supplement doses, and whether responses differ for people starting with low versus adequate vitamin D status. The goal is to identify which doses are most effective and for which groups of older adults.
What is the primary endpoint of the clinical trial?
Falls are the primary clinical endpoint for the trial described in this opportunity.
What secondary outcome was highlighted for physical function?
Gait speed was identified as a key secondary outcome to assess physical function and mobility-related change.
Why include gait speed as an outcome?
Gait speed is widely used in aging research as an indicator of mobility and overall functional status. Including it helps determine whether any effects of vitamin D extend beyond fall prevention to measurable changes in mobility and physical function.
How is baseline vitamin D status expected to be handled in the study?
The announcement indicates baseline vitamin D status matters scientifically, so the trial is expected to consider how starting vitamin D levels influence response to supplementation rather than treating older adults as one uniform group.
What type of award mechanism is used for this opportunity?
The award mechanism is a U01 cooperative agreement.
What does a U01 cooperative agreement imply about NIH involvement?
A U01 cooperative agreement means the project would be carried out with substantial NIH scientific involvement, rather than being fully investigator-driven.
How long was the project expected to run?
The opportunity describes an expected six-year effort to design and execute the randomized controlled trial.
Was there a start-up or pilot period before full-scale enrollment?
Yes. The first nine months of the award were set aside for pilot and planning activities rather than immediate full-scale enrollment.
What activities were expected during the first nine months?
During the structured start-up period, the awardee was expected to test recruitment strategies, estimate how many screened individuals are eligible and willing to be randomized, and finalize the protocol and trial operations.
What operational documents were expected to be produced during the planning phase?
The planning phase included producing data collection forms and a detailed manual of procedures to standardize operations across sites and ensure consistent outcome measurement, participant follow-up, and safety monitoring.
What kind of trial design approaches were encouraged?
NIA encouraged advanced, cost-efficient trial designs, particularly designs that begin with a dose-ranging phase and then transition into an efficacy phase focused on the most promising dose levels. Adaptive approaches were specifically highlighted as examples.
What does “well-powered” mean in the context of this trial?
Within the context of the announcement, “well-powered” indicates the randomized trial should have enough statistical power to detect meaningful differences in fall outcomes between vitamin D dose groups.
Beyond falls, what broader impacts was the study expected to examine?
In addition to fall prevention, the trial was expected to evaluate whether any observed benefits extend to measurable changes in mobility and physical function, including gait speed.
What funding category and program area was this opportunity associated with?
This opportunity was categorized as discretionary funding under the NIH activity category of health, with CFDA 93.866 (Aging Research).
Was cost sharing or matching required?
No. The announcement states that cost sharing or matching was not required.
Which types of U.S.-based applicants were eligible to apply?
Eligible applicants included a broad range of U.S.-based organizations, including public and private higher education institutions, nonprofit and for-profit organizations, small businesses, state and local governments, tribal governments and organizations, school districts, and community-based or faith-based organizations.
Were minority-serving institutions included in the eligibility list?
Yes. The eligibility list explicitly included categories of minority-serving institutions such as HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, Alaska Native and Native Hawaiian serving institutions, and it also included U.S. territories or possessions.
Were foreign institutions eligible to apply?
No. Foreign institutions and non-U.S. components of U.S. organizations were not eligible for this announcement.
Were foreign components allowed under NIH policy for this opportunity?
No. The announcement states that foreign components were not allowed under NIH policy for this specific opportunity.
When was the opportunity posted and when did it close?
The announcement was posted on July 8, 2013, and the original and current closing date was September 23, 2013.
Is this funding opportunity still open?
No. The solicitation was archived on October 24, 2013, and is no longer open.
What makes this opportunity distinct from a standard clinical trial grant?
Key distinguishing features described include the U01 cooperative agreement structure with substantial NIH scientific involvement, an explicit requirement for a large, well-powered randomized trial, a strong emphasis on dose-response across multiple doses and baseline vitamin D levels, encouragement of adaptive and cost-efficient designs, and a structured nine-month pilot/planning phase before full implementation.
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