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Date : 2019 Thursday 23 May
Code 1

Megaproject

"Evaluation of the status of primary osteoporosis and the effect of 3 interventions of curcumin, black currant, curcumin and black currant on the related cell-molecular and clinical consequences in postmenopausal women in Tabriz"
 

Megaproject is a university project run by the Center for Physical Medicine and Rehabilitation.
 
The first stage of this Megaproject on May 28, 2012 was conducted with the aim of determining the prevalence of osteoporosis and its related factors after obtaining permission from the Honorable Committee of Ethics and obtaining permission from Tabriz provincial health center on 528 postmenopausal women in Tabriz.
For the entire city to participate in the study, there are 87 health centers in Tabriz asking for help from a colleague, listing the list of all postmenopausal women aged 50 to 65 with the name of the center, their telephone number and their address from No. 1 The last one was obtained from Tabriz Health Center, which was selected three times by using the website www.random.org. Then, they were contacted by selected postmenopausal women. A brief description of the goals and method of conducting the research was explained and the criteria of the study were examined. If the conditions and willingness to participate in the study were requested, they were requested at the time at the Center for the Study of Physical Medicine and Rehabilitation was attended, the objectives of the study were fully explained at the meeting and the criteria of the study were re-examined.
10 cc Blood samples for primary tests to reject secondary causes of osteoporosis such as CBC / diff, thyroid tests, ALP, Cr, FBS, Ca, Vit D, P, and serum osteogenic tests and markers, inflammatory and oxidative markers, serum calcium levels , 25-hydroxyvitamin D, and genetic tests including genetic polymorphisms and circulating micro-RNAs, and sent to relevant laboratories (Nutrition Research Center and Pharmaceutical Research Center). The analysis of body components was done by a pneumatic composting device. If the test results are normal and the causes of secondary osteoporosis are not met, the postmenopausal woman for DEXA (Dual-Energy X-ray absorptiometry) from the two regions of the waist and femur after referring to the Bone Disease Center in Sina given. The final diagnosis and diagnosis of osteoporosis was done by the endocrinologist. All women were re-invited and the condition of their initial tests and their densitometry results were reported. For women with osteoporosis and osteopenia, treatment began in accordance with the national protocol.
 
second stage
This phase is a triple blind randomized controlled trials study. This step was completed on 07/07/2014 after obtaining permission from the Compliance Committee of the Ethics and Testing Registry at the Iranian Center for Advanced Therapies, following the first phase of the study on eligible women diagnosed with primary osteoporosis. Women with osteoporosis were randomly assigned to randomly block randomization using blocks 4 and 8 and RAS software (Random Allocation Software) and assignment ratio 1: 1: 1: 1 to four groups: 1) receptor; 2) receptor The curcumin capsule was received by the capsular receptor-curcumin capsule and the recipient of the placebo capsule, and they were told they will receive the medication for 6 months. In group 1, a capsule of 1000 mg of black currant per day and one curcumin placebo, in group 2, a 80 mg capsule of nannymequercine and a blackheaded platypus, in group 3, two capsules: a capsule of nano-mucus curcumin and a black crayon capsule; Group 4 received two placebo capsules in group 4.
For each participant, a large envelope was placed inside each large envelope with 3 small matte insert packs containing 60 capsules for two months. First, supplements were questioned and people were included in the study if they did not have a contraindication. The large envelopes, respectively, were entered by participants at this stage 1, and a small envelope containing the drug for two months plus a checklist for drug registration was provided to the collaborator, and it was recommended that two months later, upon completion of the medication, the research center Physical medicine and rehabilitation, and the delivery of the completed checklist and the previous envelope, receive the second pack containing the drug, and this will continue until the end of six months. It is necessary to explain that all groups receive Alendronite 70 mg once a day and calcium supplements and D (including 500 mg of calcium 400 units of vitamin D) daily and the recommendations for the main food containing calcium with the printed leaf of the main food containing calcium and Their amounts and daily requirement, as well as the recommendations for avoiding food intake, and the factors associated with reducing and increasing the density of acetone, as well as effective physical activity in increasing bone density. At the end of the second month, providing supplements and routine treatments and nutritional counseling and advice on physical activity, a quality of life questionnaire, and a 24-hour food registration form (a questionnaire by the contributor or in case of illiteracy by one person The family was completed at home on three occasions in two non-holiday days and one weekend in a week). At the end of the fourth month, the quality of life questionnaire was completed and the previous recommendations for repeat and routine treatment and supplements, and a checklist for taking the drug and receiving the empty doses of the drugs were done. Most of the participants have been treated for up to 4 months and now receive supplements for the last two months.

 
It should be noted that 9 student proposals resulting from this Megaproject have been drafted, approved and approved by the Code of Ethics.
 
next actions
After the intervention, from February 1, 2013, bone density measurement with DXA and serum bone marrow markers, inflammatory and oxidative markers, serum calcium and vitamin D levels and circulating micro-RNAs will be performed, and component analysis The body will be co-winded by the wind device. Also, a specific quality of life questionnaire on menopause, anthropometric checklist and hypertension will be completed again. The 24-hour food registration form will also be renewed for two non-holiday days and a one-day holiday.
Blood samples will be restored for tests to measure bone turnover markers, inflammatory microRNAs, serum infectious biosorths and oxidative stress, calcium, and 25-hydroxyvitamin D, and will be co-administered with the previous samples that were frozen by one person and one kit. Under the same conditions, they will be examined and measured.
 
It should be noted that this Megaproject is run by Dr. Aziza Farshbaf Khalili.

The main contributors are as follows:
Mr. Dr. Shakouri
Mr. Dr. Master Rahimi
Mr. Dr. Majid Motahsari
Mr. Dr. Farajnia
Mrs. Dr. Mirghforund
Worked by Dr. Dodkhah
Ms. Dr. Mohammad Alizadeh