Project Placebo

 

“Radiation monitoring of the children living in Chernobyl zone of Belarus, their radiation protection and determining the effectiveness of the protection with the pectin preparations “Vitapect”.

  

 

Republic of Belarus  -  Institute of Radiation Safety “Belrad”

 

 


 

  

Minsk  -   2001

 

 

Program

 

 

 

“Radiation monitoring of the children living in Chernobyl zone of Belarus, their radiation protection and determining the effectiveness of the protection with the pectin preparations “Vitapect”.

 

1.      Program aim:

 

1.  to compare the decrease of the incorporated 137Cs in children’s organism in the group taking the preparation  containing pectin  and in the group of children taking placebo (preparations – with numbers and not identified).

2.  to assess the individual reaction and the tolerance of the preparation.

 

2.      Program Participents.

 

2.1.  Institute of Radiation Safety “Belrad”:

 

Chief researcher: Vasily Borisovich  Nesterenko,

                               Corresponding member of

                               the National Academy of Sciences of Belarus,

                               Doctor of Technical Sciences, professor.

                               220002 Minsk, V. Khoruzhey street 31a, IRS “Belrad”

 

Pediatrician realizing the research: Galina Sergeyevna Bandazhevskaya

                                                             Assistent professor,

                                                             Candidate of Medical Sciences, Gomel

Statistician: Yerkovich Tatyana Valeryevna

Engineer of the IRS “Belrad”

220002 Minsk, V. Khoruzhey street 31a, IRS “Belrad”

 

2.2.  Sanatorium-preventive clinic “Khimvolokno” , the city of Svetlogorsk, Gomel region.

 

Head: Pavel Andreyevich Malashenko

Chief physician of the sanatorium-preventive clinic “Khimvolokno”,

Svetlogorsk of Gomel region

 

2.3.  Secondary school of the village Litvinovichi of Korma district of Gomel region.

Director of the school: Vasily Grigoryevich Ganzhurov

 

2.4. Ethic committee.

 

Tamara Andreyevna BIRICH – a professor, Doctor of Medicine, head of the department of the Minsk State Medical University.

Father Fyodor (Fyodor petrovich Povny) – an archpriest, dean of the Orthodoxen parish in honor of all Holies. 

 

 

3. work scheme.

 

It is proposed to use the following work scheme:

1.      The measurement of the radionuclide concentration in the organisms of the children living in Chernobyl zone of Belarus with the help of  the automated complex of  the human internal radiation “SKRINNER-3M” is to be implemented in two stages:

-          in the sanatorium-preventive clinic “Khimvolokno”  the city of Svetlogorsk of Gomel region;

-          in the secondary school of the village Litvinovichi of Korma district of Gomel region.

2.      According to the result of the measurements groups for taking preparations “Vitapect” and “Placebo” are to be determined.

3.      The written permission of the parents is to be received. The questionnaire is filled for each child. Each of the parents has a right to stop his or her child participation in the program.

4.      The children take the preparations under observation of physicians during 21 days.

5.      Checkup is being made by a cardiologist and an oulists at this period.

6.      At the end of taking preparations the second measurement for determining the effectiveness of the decrease of the radionuclide concentration in children’s organism is to be implemented.    

 

The main measurement is a determination of the specific activity of g-radiating nuclides (137Cs, 134Cs).

 

Statisticians will compare data variations between the first and the second measurements, before and after the 21st day. They will note the data which remain stable, and the data which increase and decrease.

 

The statistician will determine if the variations between groups are statistically important. The statistician will work having not got an idea which medicine is used but having got an idea to which group (A or B) the child refers.   

 

4. Work Plan

 

Taking into account the Institute of Radiation Safety “Belrad” the present program will include the following works:

I. Stage  

 

Sanatorium-preventive clinic “Khimvolokno”,  Svetlogorsk, Gomel region;

 

June 2001

1.      radiological checkup of 550 children being on rehabilitation in sanatorium-preventive clinic “Khimvolokno” on the spectrometer of the human radiation “SKRINNER-3M”;

 

2.      according to the results of the SHR-measurements the group of children  at the age of  7-11 having the specific activity which is higher than 15 Bq/kg will be selected;

 

3.      two groups from 32 persons each are to be determined for taking pectins and placebo:

- the first group “A” from 32 persons will receive the pectin preparation “Vitapect” 2 times a day (daily norm is 10 grams);

- the second group “B” from 32 persons will receive the preparation “Placebo”  2 times a day;

4.      the children’s weight will be checked up before and after the 3-week rehabilitation;

5.      the second checkup of all groups on the SHR for assessing the effectiveness of the use of all preparations;

6.      for getting  the parents’ permission for their children to participate in the Program the trip to the places of their residence will be organized.

 

7.   à la fin du test, tous les enfants du groupe "B" recevront le produit à base de pectine "Vitapect".

 

II. Stage  

 

The village Litvinovichi of Korma district of Gomel region.

 

1st part: September 2001.

 

1.      Before starting the measurements it is expected to carry out a seminar, it is planned to invite the parents and the teachers from the school where the tests will take place. At the seminar it is necessary to explain the representatives of the schools the gist of the project,  to familiarize with methods of testing, to provide them with study aim in radiation protection, brochures in which  the basic aims and tasks of the project are formulated and the basic measures of radiation protection, open to each inhabitant, are represented.

 

2.      radiological checkup of 350 children on the spectrometer of the human radiation “SKRINNER-3M”.

 

When measuring the children on the spectrometer of human internal radiation “SKRINNER-3M” (SHR) the children are being examined by the cardiologist and the oculist (by the cardiologist during each checkup). 

 

3.      two groups 175 persons each are to be determined for taking pectins and placebo:

- the first group “A” from 175 persons will receive the pectin preparation “Vitapect” 2 times a day (daily norm is 10 grams);

- the second group “B” from 175 persons will receive the preparation “Placebo” 2 times a day (daily norm is 10 grams);

4.      the children’s weight will be checked up before and after the 3-week usage of the preparations;

5.      the second checkup of all groups on the SHR for assessing the effectiveness of the use of all preparations.

6.      The children from the groups “A” and “B”  trade places:

- the first group “A” from 175 persons will receive the pectin preparation “Placebo” 2 times a day (daily norm is 10 grams);

-          the second group “B” from 175 persons will receive the preparation “Vitapect” 2 times a day (daily norm is 10 grams);

7.      the third checkup of all two groups on the SHR for assessing the effectiveness of the use of preparations;

8.      on completing the tests it is supposed to carry out the final seminar in order to sum up the results of the researches with participation of representatives of the schools and mass media.

 

5. Type of the research

 

Mutual comparison (with mutual ignorance) of the results of two preparations: pectin and placebo.

Neither physicians nor parents will know which preparation the child will take.

The parents’ permission is to be in written form. Each of them can stop the participation.

The preparation will be taken as a powder under the nurse’s and parents’ observation. The preparations will contain a fruit flavor in order not to differentiate pectin and placebo.

The children are to be numbered from 1 to 32 (sanatorium “Khimvolokno” and from 1 to 175 (village Litvinovichi) receiving the letters “A” and “B” to the groups after having received the parents’ permission and the doctors agreement for the child to be tested if the health conditions were good.

All packets will be filled with one of two preparations (A and B); all packets will have the same number as the child will have.

On the expiry of 21 research days when each child’s results are noted, the sealed box will be opened and the assessment will take place. In case of an undesirable disease the envelope with the adequate number can be opened. The number of stops during the research will be noted.

 

6. PARAMETERS (EFFECTIVENESS AND TOLERANCE)

 

The pediatrician is responsible for safety and for doctor’s mutual checkup before and after participating in the Program.

Taking blood and a laboratory research are not expected because pectin is a food that can be bought for preparing jams and cakes. But if the doctor wants to make a routine analysis of urine before and after testing it is possible but for all children.

The children’s weight will be checked up before and after the 3-week treatment.

School absences, complaints and doctor’s visits caused by undesirable diseases should be noted. All thing which can be considered as secondary effects should be also noted. Subjective aspects, for example whether the child feels bad or good, is tired, is more or less out of breath when playing should be also noted.

The nurse under pediatrician’s supervision can fill children’s questionnaire.

 

7. Program  Participants’ Duties

 

7.1 The Institute of Radiation Safety “Belrad” implements the measurements of the radionuclide concentration in the organisms of the children and the parents spending their holidays at the sanatorium “Khimvolokno” with the help of  the automated complex of  the human internal radiation “SKRINNER-3M”. According to the results it determines the groups for taking the preparations.

7.2 The Institute of Radiation Safety “Belrad” implements the measurements of the radionuclide concentration in the organisms of the children in the secondary school of the village Litvinovichi of Korma district of Gomel region with the help of  the automated complex of  the human internal radiation “SKRINNER-3M”. According to the results it determines the groups for taking the preparations.

7.3 The Institute of Radiation Safety “Belrad” gives the pectin preparation “Vitapect”.

7.4  The Institute of Radiation Safety “Belrad” gives the preparation “Placebo”.

7.5 Medical stuff implements the giving out the preparations and supervises their usage by the pupils, fill in the form for each child, note their complaints and state of health.

 

8. Terms of the fulfillment of the works

 

Terms of the fulfillment of the works under the program: June – November 2001.

 

9. Publication of the Results

 

The received data will be published by the professor V.B. Nesterenko and the pediatrician who is responsible for the clinical checkup  of the children during and after completing the 3 week research.

Those who took part in woks connected with these tests can be considered as co-authors.

10. Work Prices

 

Work prices under this Program will made:

1.      1st stage – sanatorium-preventive clinic “Khimvolokno” of Svetlogorsk – 5480 (five thousand four hundred eighty) US dollars.

2. 2nd stage - village Litvinovichi of Korma district of Gomel region – 28592 (twenty five thousand five hundred ninety two) US dollars.

Form of payment – cashless settlement.

The Project is implemented due to charitable donations of the Customer.

 

In Appendix 1 there is a calculation of work prices in the village Litvinovichi of Korma district of Gomel region.

In Appendix 2 there is a calculation of work prices in the sanatorium-preventive clinic “Khimvolokno”.

 

The Program was worked up and discussed by:

 

Director of the Institute of

Radiation Safety “Belrad”

Corresponding member of the

National Academy of Sciences of Belarus

Professor, Doctor of  Technical Sciences                                              V.B. Nesterenko

 

Chief physician of the

sanatorium-preventive “Khimvolokno”                                               P.A. Malashenko

 

 

 

 

 

Test Protocol

 

Pectin, for bringing down chronical 137Csaccumulation in children’s organism

 

Chief researcher: Vasily Borisovich  Nesterenko,

                               Corresponding member of

                               the National Academy of Sciences of Belarus,

                               Doctor of Technical Sciences, professor.

                               220002 Minsk, V. Khoruzhey street 31a, IRS “Belrad”

 

Pediatrician realizing the research: Galina Sergeyevna Bandazhevskaya

                                                             Assistent professor,

                                                             Candidate of Medical Sciences, Gomel

 

Ethic committee: Tamara Andreyevna Birich, professor,

                              Doctor of Medicine,

                              Head of the Department of the Minsk State Medical University

 

                              Fyodor Povnyan archpriest, dean of the

                              Orthodoxen parish in honor of all Holies. 

 

Physicians who are responsible for control:

 

Head: Pavel Andreyevich Malashenko

Chief physician of the sanatorium-preventive clinic “Khimvolokno”

Svetlogorsk,

Gomel region

 

Physician:____________________________________________________________

 

_____________________________________________________________________

 

 

Statistician: Yerkovich Tatyana Valeryevna

Engineer of the IRS “Belrad”

220002 Minsk, V. Khoruzhey street 31a, IRS “Belrad”

 

 

Sources of financing of the research:_______________            _________________

  

_____________________________________________________________________

 

 

 

 

 

 

 

 

Appendix No. 1

dated “___”_________2001

 

„Approved“

by the Director of the Institute

of Radiation Safety „Belrad“

____________V.B. Nesterenko

„___“_____________2001

 

 

CALCULATION of  WORK PRICES

 

under  the Program  dated «___»__________ 2001

"RADIATION MONITORING OF THE CHILDREN OF THE VILLAGE LITVINOVICHI OF KORMA DISTRICT OF GOMEL REGION ,  THEIR RADIATION PROTECTION  AND  DETERMINING the EFFECTIVENESS OF THE PROTECTION WITH THE PECTIN PREPARATIONS “VITAPECT”

 

 

Expenses

Total

 

     Primary seminar with a participation of 20 persons

Travel 20 persons*3$*2

Hotel 20 persons*2 days*5$

Food 20 persons*3 days*8$

Preparing materials

20 sets of distributing materials*4$

Making materials

Making an original-prototype 50 pages *2$

Renting an assambley hall 3 days * 50$

Renting an equipment 3 days * 20$

Lectors, experts 4 persons * 3 days * 20$

Taxes 40%

TOTAL

 

     Final seminar with a participation of 20 persons

Travel 20 persons*3$*2

Hotel 20 persons*2 days*5$

Food 20 persons*3 days*8$

Preparing materials

20 sets of distributing materials*4$

Making materials

Making an original-prototype 50 pages *2$

Renting an assambley hall 3 days * 50$

Renting an equipment 3 days * 20$

Lectors, experts 4 persons * 3 days * 20$

Taxes 40%

TOTAL

 

     Checking up children’s eyesight

Checkup of 350 persons * 2$
TOTAL

 

     Participants’ wages

Project leader 500$*2 months

Analytical group 1 person * 120$ * 2 months

SHR-laboratory  8 persons * 120$ * 2 months

Accounts department 5 persons * 80$ * 2 months

Office 2 persons  * 80$ * 2 months

Information centre 4 persons * 120$ * 2 months

Cardiologist 1 person * 120$ * 2 months

Eye doctor 1 person * 120$ * 2 months

Drivers 4 person * 40$ * 2 months

TOTAL

 

     Wage taxes 40 %

TOTAL:

 

 

 

The first SHR-checkup 350 persons *2 $

Cardiography    350 persons * 2  $

Pectins     175 persons * 5 g *2 times a day * 21 days  = 36750 g*0.02$     

“Placebo”   175 persons *5 g * 2 times a day * 21 days =36750 g *0.01$

 The second SHR-checkup 350 persons *2 $

Cardiography 350 persons * 2  $

Pectins     175 persons * 5 g *2 times a day * 21 days  = 36750 g*0.02$     

“Placebo”   175 persons *5 g * 2 times a day * 21 days =36750 g *0.01$     

School representative’s wages who is responsible for taking preparation

Wage tax 40 %

The third SHR-checkup 350 чел. *  2$

      Cardiography    350 persons * 2 $

School representative’s wages who is responsible for taking preparation

Wage tax 40 %

Travel allowance:

1 tour- 4 persons * 6 days* 8 $

                4 persons * 5 days*8 $

2 tour – 4 persons * 6 days * 8$

                    4 persons * 5 days * 8 $

3 tour – 4 persons * 6 days * 8$

                    4 persons * 5 days * 8 $

Transport charges:

0.1$ * 800 km * 3 tours

800 km: 50 km/h *4 $ * 3 tours

TOTAL:

 

        

 

120

200

480

 

80

250

100

150

60

240

196

1776

 

 

120

200

480

 

80

250

100

150

60

240

96

1776

 

 

700

700

 

 

1000

240

1920

800

320

960

240

240

320

6040

 

2466

2466

 

 

 

700

700

735

367

700

700

735

367

40

16

700

700

40

16

 

192

160

192

160

192

160

 

240

192

8004

Publishing the final report and translating it into English

500

Giving the brochures “Recommendations on measures of radiation protection of the population and their effectiveness” (author V.B. Nesterenko) to the teachers and parents  200 brochures x 10 USD

2000

    Information programs

Preparing and writing booklets

Designing calendars and posters 

Total

 

     Publications

840 publications * 5 $

Total                                                                                                         

 

     Preparing and making a web-site                                         

Hosting 12 months * 20 $

Developing and designing a web-site

Every month renewal

      TOTAL:

 

 

500

500

 

               

        4200

        4200

    

 

240

200

240

680

 

Sum total:  28592

 

Economist                                                                                         Ye.A. Shust

 

 

 

                                                                                    Appendix No. 2

dated “___”_________2001

 

„Approved“

by the Director of the Institute

of Radiation Safety „Belrad“

____________V.B. Nesterenko

„___“_____________2001

 

 

CALCULATION of  WORK PRICES

 

under  the Program  dated «___»__________ 2001

 

"RADIATION MONITORING OF THE CHILDREN being on rehabilitation at the sanatorium-preventive clinic “Khimvolokno” from the places of Belarus suffered from the Chernobyl catastrophe, THEIR RADIATION PROTECTION  AND  DETERMINING the EFFECTIVENESS OF THE PROTECTION WITH THE PECTIN PREPARATIONS “VITAPECT”

 

No.

EXPENSES

price

 

 

USdollars

1

Price of the first checkup of  550 persons on the SHR: 2 $  х 550 persons.

1100

2

Price of pectin for the group “A”:

32 persons x 10 grams x 21 days = 6720 grams : 150 grams (weiht of one can) = 45 cans x 3 USD = 135 USD

135

3

Price of pectin for the group “B”:

32 cans x 3 USD = 92 USD

96

4

Price of placebo for the group “B”:

32 persons x 10 grams x 21 days = 6720 grams : 0,0024 USD =

= 23 USD

16

5

Price of the second checkup of  250 persons on the SHR: 2 $  х 250 persons.

500

6

Transport charges for the trip to the sanatorium “Khimvolokno”:

2 trips /1 car/ 700км:

0,18 USD x 70 km x 2 trips = 252 USD and

700 km : 50 km/h x 4 USD x 2 trips = 112 USD

364

7

Travel expenses:

daily allowance: 3 persons х 2 trip х 6 days x 8 USD = 288 USD 

hotel: 3 persons х 2 trip х 5 days x 8 USD = 248

528

8

Transport charges for the trip to the villages, places where the children participating in the program live, in order to collect their parents’ signatures:

1 trips /1 car/ 2000км:

0,18 USD x 2000 km x 1 trips = 360 USD and

2000 km : 50 km/h x 4 USD x 1 trips = 160 USD

520

9

Travel expenses:

daily allowance: 3 persons х 5 days x 8 USD = 120 USD 

hotel: 3 persons х х 4 days x 8 USD = 96

216

10

Oculist’s wages

100

11

Cardiologist’s wages

100

12

Publishing the final report and translating it into English

250

13

Analysis, data processing of the results of the SHR-measurements and publishing the bulletin

760

14

Traslating the bulletin into English, German, French, its publication

795

total:

5480

 

 

 

Economist                                                                                    Ye.A. Shust

 

 

 

Source W.T.