vIVID Study

Hepcidin, Iron and Vitamin D status in Middle Eastern and South Asian Females

Information Sheet -  vIVID Study Information sheet1.pdf (425 KB)

Introduction

We would like to invite you to participate in this study investigating iron and vitamin D status. The purpose of this research is to learn more about iron and vitamin D deficiency in Middle Eastern and South Asian women living in Auckland, New Zealand, and identify risk factors, metabolic biomarkers and genetic factors associated with the development of these nutrient deficiencies. This study is being conducted by a group of researchers at Massey University, Auckland New Zealand.

Please read the Information Sheet carefully before deciding whether or not to participate

Why are we doing this research?

Within New Zealand approximately 12% of premenopausal females are diagnosed with iron deficiency. Research from Massey University has identified that females of Asian origin are 5 times more likely to be iron deficient, however, we don’t really know why. Middle Eastern and South Asian women are often diagnosed with vitamin D deficiency and iron deficiency. Changes in season and lifestyle factors (e.g. clothing, food choice) may be contributing to the development of these nutrient deficiencies. If left untreated these deficiencies can develop into chronic health conditions including poor muscle strength and bone health, poor immune function,  type II diabetes and cardiovascular disease. This study will aim to assess the current relationship between hormones, genetics, iron and vitamin D status in South Asian and Middle Eastern women residing in Auckland, New Zealand.

Who are we looking for?

We are looking for 235 females to participate in this study. To take part in the study you should:
-    Be between 18-40 years of age
-    Be of Middle Eastern and/or South Asian descent (preferably the participant or both of their parents should be born in a South Asian or Middle Eastern country)
-    Be proficient in English (able to speak and read English)
-    Not consumed iron, vitamin C or calcium supplements (or supplements that contain these nutrients) in the previous 3 months.


-    Not have donated blood for 6 months prior to the study.
-    Not be pregnant or currently breastfeeding.
-    Have no known health problems likely to influence iron status including inflammatory bowel disease, celiac disease, history of gastric ulcers, disorders of red blood cells, menorrhagia, piles, blood in the urine or malaria.

What is going to happen?

If you decide to take part in this study after you have read and had time to consider the information contained in this information sheet, you will be asked to complete a short screening questionnaire to ensure that you meet the study criteria. If you meet the inclusion criteria you will be invited to take part in the study. If you are willing to participate, you will be invited to attend a single session between the hours of 6:00-12:00 pm (Noon), lasting 60 minutes at the School of Sport, Exercise and Nutrition laboratory. The laboratory is located in Building 60, Massey University Oteha Rohe Campus, Albany Highway, Albany, Auckland, New Zealand.
-    At this session you will be asked to sign a consent form for participating in the study and you will have the opportunity to ask any questions about the study.
-    You will be reimbursed for your travel costs to Albany.
-    You will be seated in a quiet room and asked to complete a series of online questionnaires in private.
-    The information that will collected from these questionnaires will include; age, ethnicity, socioeconomic status, medical history (including medication and/or supplement use), skin colour, sun exposure, physical activity level, dietary iron intake, alcohol and smoking status and blood loss.
-    In a separate private room your height will be measured using stadiometer. In the same private room your body composition and body weight (lean body mass and percentage body fat) will be measured using the bioelectrical impedance analysis machine (BIA).  The BIA measures body composition and percentage of body fat by running a very low level of electrical current through electrodes attached to hands, feet.  You will not feel this current.  Testing is highly accurate, safe, and quick, completed in less than 5 minutes. Only yourself and a female researcher will be allowed in this room. If you have a pacemaker and/or Implantable Cardioverter Defibrillators then your weight will be collected by a standard scale only.
-    In another private room blood pressure will be collected using a sphygmomanometer; an inflatable cuff will be placed around the top of your arm and will be inflated. This may be slightly uncomfortable for you but will not last for a long period of time (~5 seconds). The cuff will then be deflated and your blood pressure will be recorded.
-    A blood sample will be taken by a trained female phlebotomist (Dr Claire Badenhorst).  The total amount taken will be ~20 ml, equivalent to 4 x teaspoons. We will be measuring iron and vitamin D levels, hepcidin and inflammatory markers (such as C-RP, IL-6) in this blood sample.  
-    We will also be analysing the blood sample for the vitamin-D binding protein (VDBP) gene and vitamin D receptor (VDR) gene. Analysis of these genes may help us understand why some people need more vitamin D than others. Only these genes will be identified, however if you wish to not have these genes analysed you are free to request that they are not part of the study. Please let the female researcher or Dr Claire Badenhorst know at the commencement of the study.
-    Participants will be provided with water, tea and or coffee and a small snack following blood sample collection.

Data Management

The data will be used only for the purposes of this project and no individual will be identified.  Only the investigators and administrators of the study will have access to personal information and this will be kept secure and strictly confidential.  Participants will be identified only by a study identification number.  Results of this project may be published or presented at conferences or seminars and no individual will be able to be identified.  
At the end of this study the list of participants and their study identification number will be disposed of.  Any raw data on which the results of the project depend will be retained in secure storage for 10 years, after which it will be destroyed.  
A summary of the project findings will be available to all study participants. All participants will be sent this information via email or a personal letter.
Who is funding the research
The research is funded by Massey University Research Fund, College of Health
Participants Rights:
You are under no obligation to accept this invitation. Should you choose to participate, you have the right to:
-    Decline to answer any particular question
-    Withdraw from the study at any time, even after signing a consent form (if you choose to withdraw you cannot withdraw your data from the analysis after the data collection has been completed)
-    Ask any questions about the study at any time during participation
-    Provide information on the understanding that your name will not be used unless you give permission to the researcher
-    Be given access to a summary of the project findings when it is concluded

What are the benefits and risks of taking part in this study?

There will be no cost to you for any of the procedures or assessments taken as part of this study. You will receive information on your body measurements, blood pressure at the end of the testing session. You iron and vitamin D status will be sent out to you (email or mail) at the completion of the study. You will also receive a brief report summarising the main findings of the project via mail or email. You will be provided with a petrol voucher for completing the study on the Albany Campus in Auckland.
The principle benefit of taking part in this study is that you will contribute to a novel area of research and assist us in increasing our understanding of iron and vitamin D deficiency in Middle Eastern and South Asian populations.


Some people may have a fear of having a blood sample taken or experience discomfort when the blood samples are taken. Occasionally a slight bruising will result.  The bruising usually disappears within a day or two.  Blood samples will be taken by a trained phlebotomist.  There may be social or cultural discomfort from having body composition measurements done or a blood sample taken, however, privacy will be ensured, and you will be treated with respect. You may also be accompanied by a support person if required.


There are no personal risks to your health, but the blood tests could potentially identify the need for follow-up with your health care provider.

Support Processes

If we find that your blood results are outside normal parameters we will discuss with you what action should be taken. You will be advised to talk to your medical practitioner or we can send your results directly to them. If as a result of this you require additional blood tests you may be liable for any costs.  You will be able to book into the nutrition clinic following the study to obtain dietary advice from a registered dietitian if desired, however, usual clinic fees will apply.

Ethics Committee Approval Statement

This project has been reviewed and approved by the Massey University Human Ethics Committee: Southern A, Application 18/12.  If you have any concerns about the conduct of this research, please contact Dr Lesley Batten, Chair, Massey University Human Ethics Committee: Southern A, telephone 06 356 9099 x 85094, email humanethicsoutha@massey.ac.nz.

Compensation for Injury

If physical injury results from your participation in this study, you should visit a treatment provider to make a claim to ACC as soon as possible. ACC cover and entitlements are not automatic and your claim will be assessed by ACC in accordance with the Accident Compensation Act 2001. If your claim is accepted, ACC must inform you of your entitlements, and must help you access those entitlements. Entitlements may include, but not limited to, treatment costs, travel costs for rehabilitation, loss of earnings, and/or lump sum for permanent impairment. Compensation for mental trauma may also be included, but only if this incurred as a result of physical injury.
If your ACC claim is not accepted, you should immediately contact the researcher. The researcher will initiate processes to ensure you receive compensation equivalent to that to which you would have been entitled had ACC accepted your claim.

Thank you for considering participation in this study.

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