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HNRCA Health & Safety Commitment on response to COVID-19

At the HNRCA, we understand that safety is of the utmost concern to everyone and our goal is to provide and maintain the safest environment possible in order to resume and continue our research study activities. We have implemented extra precautions for the health of our research study participants, visitors and staff. Below are some of the enhanced measures we have committed to use each day:

1. Symptom Screening Procedures

  • Study participants and all HNRCA staff are required to be screened for COVID-19 symptoms and exposure when entering the building. Anyone experiencing such symptoms is not allowed to continue into the building.

2. Masks, Personal Protective Equipment and Hand Hygiene

  • Masks must be worn to enter the HNRCA.
  • A new mask will be provided upon entry into the lobby and must be worn at all times by HNRCA staff, study participants and visitors.
  • HNRCA staff will wear additional personal protective equipment (such as eye protection) in instances when social distancing cannot be maintained (i.e. during blood draws).
  • CDC-approved hand sanitizer is readily available for study participant, visitor and staff use.

Staff and study participants are required to perform hand hygiene before and after all research and study related activities.

3. Building Capacity and Study Visits

  • We are limiting the number of people in our building and allowing only visitors scheduled for an appointment.
  • Some study procedures (including some prescreening procedures, questionnaires, and study check-ins) will now happen remotely via a phone or video call to help reduce the time of your study visit when possible.

4. Cleaning and Disinfection

  • All procedure and assessment rooms, as well as equipment are cleaned and disinfected after each participant use.
  • All common area surfaces (e.g. tables, chairs, check-in areas) are cleaned and disinfected frequently throughout the day


Purpose of this study
The purpose of this study is to compare different types of iron supplements on intestinal health, inflammation, and the response of immune cells to bacteria and viruses.

Target Population
Men and post-menopausal women aged 50-80 years old

Major Exclusions
BMI <18 or >35 kg/m2
• GI disease, conditions or medications known to influence GI absorption (peptic ulcer disease, IBD, Crohn’s disease, pancreatic insufficiency)

• Anticoagulants (blood thinners), aspirin, NSAIDs (non-steroidal anti-inflammatory drugs), steroids, diabetes meds
• Regular use of any dietary supplements containing vitamins and minerals; however, subjects who are willing to refrain from the use of these supplements for 2 weeks prior to their enrollment and throughout the entire study may be considered eligible; subjects will be excluded if they are taking physician prescribed vitamin and/or mineral supplements, including iron
• History of malaria, vaccination or treatment for malaria in 3 months prior to enrollment
• Daily alcohol intake of >2 drinks, or >14 drinks/week
• Irregular bowel movements (<3 times per week)

Length of Study
4 weeks

Residency
None

Number of visits
1 screening visit; 1 enrollment visit to receive stool sample collection kit; 2 study visits for collection of blood and stool samples, as well as collecting and dietary and clinical information (i.e., blood pressure, weight, etc.) at the start of the study (week 0) and at the end of the study (week 4).

Study diet
Subjects must maintain their regular diet throughout the 4 week trial.

Participants must be willing to stop all dietary supplements for the duration of the study. Participants will be asked to consume different types of iron supplements (or a placebo) provided by the Jean Mayer USDA Human Nutrition Research Center on Aging for 4 weeks

Stipend
$25 for screening, and up to $400 for participants who qualify and complete the entire study

Can I work?
Yes, but if subjects employed by Tufts University qualify to participate in the study, they cannot participate as volunteers during hours in which they are being compensated by Tufts University for their regular work. This includes the use of vacation, personal days and sick time.

NOTES:
Length of study

Total length of the study including resident stays and nonresident visits.
This does not mean you will be testing the entire time.
Residency

The length of time volunteers are required to stay overnight at the HNRCA. Residents have their own private room, bathroom, television, VCR, and phone during their stay.
Payment

The amount of reimbursement for travel and inconvenience.
Number of visits

Total number of nonresident visits.
Study diet

Indicates meals which will be provided by the HNRCA
Can I work?

Indicates if you will be able to work and if so, when.

For more information about this study, please call Volunteer Services at 1-800-738-7555 .

We appreciate your interest in our program and we hope to work with you in the future.

Thank you,
The Recruitment Office
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University