PLXCOM Iron | Screening Script IRONPK Iron Absorption Study "*" indicates required fields Short Term Absorption Study • Introduce yourself (name, role, and company) • Tell the potential participant you are calling following their expressed interest in one of our trials. RDC Clinical is a clinical research organisation within the industries of complementary medicines, dietary supplements, foods and cosmetics. RDC Clinical is working in collaboration with The University of Queensland to conduct this clinical trial. What is the trial This trial is a double-blind randomised controlled, cross-over study conducted in healthy participants aged 18 years and older. The study is testing the absorption of Iron and you will be required to take and 4 iron supplement with different doses (3 with 20 mg and 1 with 100mg) for a total of 160mg. This study aims to compare the absorption of a single dose of Iron with and without absorption enhancing technology in healthy participants over a period of up to 10-hours. As this study is a cross-over study, you will be required to take a single dose of all 4 supplements being tested, separated by a minimum 2 week washout period The study dates for this study are as follows: Study Program Dates: Round 1 Tuesday November 18th Day 1 : 6:30am to approximately 6.00pm Wednesday November 19th Day 2 : Approximately 30 minutes (between 6.30am and 8.30am) Thursday November 20th Day 3 : Approximately 30 minutes (between 6.30am and 8.30am) Round 2 Tuesday December 2nd Day 1 : 6:30am to approximately 6.00pm Wednesday December 3rd Day 2 : Approximately 30 minutes (between 6.30am and 8.30am) Thursday December 4th Day 3 : Approximately 30 minutes (between 6.30am and 8.30am) Round 3 Tuesday December 16th Day 1 : 6:30am to approximately 6.00pm Wednesday December 17th Day 2 : Approximately 30 minutes (between 6.30am and 8.30am) Thursday December 18th Day 3 : Approximately 30 minutes (between 6.30am and 8.30am) Round 4 Tuesday January 6th Day 1 : 6:30am to approximately 6.00pm Wednesday January 7th Day 2 : Approximately 30 minutes (between 6.30am and 8.30am) Thursday January 8th Day 3 : Approximately 30 minutes (between 6.30am and 8.30am) Your total involvement in this study will be approximately 8 weeks in total. You are required to attend 3 consecutive clinic visits for each supplement. For a total of 12 clinic visits over the 8 weeks. Each supplement dose will require you to attend 1 full in-clinic day of up to 12 hours and 2 follow-up clinic visits of up to 30 minutes, 24 and 48 hours after taking each supplement. You will then be required to return to the study site a minimum of 2 weeks later for a repeat of the study with the second supplement dose, and repeat this process again for the 3rd and 4th supplements. Therefore, your time involvement in this trial will be up to 52 hours in total over approximately 8 weeks. On each of the full day clinic visits, you will be required to arrive fasted, and have a cannula inserted into your arm. This will be used to take blood from you throughout the day to avoid having to repeatedly insert a needle. Have you had a cannula before? • If yes, move on • If no explain what it is and that it will stay in the arm On each of the follow-up visits, you do not need to be fasted, and will only have a single blood sample taken. Over the 8 weeks of the study, we will take approximately 400 mL of blood from you. This represents approximately 8% of your blood volume and will not compromise your health. If you complete the study, you will receive a $1000 payment. Are you still interested in proceeding with the trial? • If no, thank them for their time and wish them well. • If yes, proceed to the screening criteria. Now I will go through some screening questions with you to see if you’re eligible to participate. The majority of the questions are to do with your health history. Trial Coordinators Initials* Participant still interested after study summary?* Yes No Initials of participant that is not interested in continuing to screening... Screening QuestionsGender?* Female Male Other Are you currently pregnant or breastfeeding? Yes No Not Eligible Are you aged over 18 years old? Yes No Not Eligible Are you able to attend the Fortitude Valley clinic on the study dates? Yes No Not Eligible What is your height?(in metres)What is your weight?(in kilograms)BMI CalculationCalculate BMI for eligibility – If 18.5-29.9 continue, otherwise ineligible Not Eligible Do you have normal dietary habits (with no significant changes to diet within the past 1 month)? Yes No Not Eligible Do you agree to not to change current diet and/or exercise frequency or intensity during entire study period? Yes No Not Eligible Do you have any serious illnesses or mood disorders such as depression, anxiety or bipolar disorder, neurological disorders, MS, kidney disease, liver disease or heart conditions? Yes No Not Eligible Have you had cancer or treatment such as chemotherapy or chemotherapy or radiotherapy treatment in the last 2 years?Basil Cell Carcinoma is ok Yes No or BCC only Not Eligible Do you have any long-term prescription medication use (besides contraceptive pill)?Long term medications (more than 2 months) are an exclusion criteria Prescribed birth control, and occasional use of ibuprofen/paracetamol is ok. Yes Yes - Birth control or occasional Ibuprofen/Paracetamol only No Not Eligible Are you currently taking any supplements including any vitamins, herbs, or minerals? Yes No Please list any medications or supplements belowAll long term medications excluded except birth control, hormone replacement therapy and occasional Panadol/ibuprofen useNameDoseFrequencyReasonPrescribed? (Y/N) Add RemoveDo you have any known allergies to any of the ingredients in the study products?Iron, Lipisperse Yes No Not Eligible Have you been regularly taking any products containing Iron in the past month? Yes No Not Eligible Are you taking anticoagulant drugs (e.g., Warfarin)? Yes No Not Eligible Do you consume more than 21 standard alcoholic drinks per week? Yes No Not Eligible Do you smoke/e-cigarettes or use recreational drugs? Yes No Not Eligible Have you participated in another clinical trial within the previous month? Yes No Not Eligible Screening Result? Passed Failed need to check Waitlisted Screen Fail Reason / Notes :Thank you for answering those questions. Are you happy to continue with enrolment? Yes No I will now assign you a Participant ID which will be used throughout the study on any information/data that we collect from you. Your Participant ID will be your initials followed by the first 4 digits of your date of birth. Can I please ask the day and month of your birth date?Participant ID* Do you have any questions about your participation in the study? Now that you have completed the screening process, if you are happy to proceed, I would like you to sign our electronic consent form. You will receive a link in an email shortly to a secure page where you can sign. Please be aware that we do not offer parking for our short-term absorption studies due to the number of participants. We are located close to bus stops and a short walk from Fortitude Valley train station. On the day, please be sure to arrive on time, and fasted. No food or drink except water from 10pm the night before. We will provide all food on the day, as all participants are required to consume the same diet, please don't bring any food from home. You are welcome to bring devices to connect to our wifi, please remember to bring headphones for noisy activities for the comfort of other participants.
