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| Name | Class |
|---|---|
| Rikshospitalet University Hospital | OTHER |
| National Institute for Occupational Safety and Health (NIOSH/CDC) | FED |
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The aim of the study is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).
OBJECTIVE:
Cement dust is suspected to be one of the main factors causing increased mortality among workers not only in the cement production industry, but also in the construction industry worldwide. Our aim is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).
METHODS:
All employees from Norwegian cement plants, are invited to participate. The workers will perform spirometry, single-breath determination of carbon monoxide uptake, blood samples before and after a working shift of 6-8 hours, and again after 24 hours. Information on respiratory symptoms, allergy and former respiratory disease as well as exposure information will be given on a self-reported questionnaire. Changes in lung function indices, nitric oxide levels and serum inflammatory markers will be calculated. Nitric oxide will only be measured in non-smokers. We will compare cement dust exposed workers with low-level or non-exposed workers (controls).
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Lung Function Measurements During One Work Shift (6-8h) | Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity | baseline and 6-8h |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in FeNO Measurements During One Shift (6-8h) | baseline and 6-8h | |
| Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h) | Baseline and 6-8h | |
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Inclusion Criteria:
Exclusion Criteria:
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All employees of two Norwegian cement production plants are invited to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Johny Kongerud, MD, PhD | Rikshospitalet University Hospital | Study Chair |
| Helge Kjuus, MD, PhD | National Institute of occupational Health, NIOH | Study Chair |
| Marit Skogstad, MD, PhD | National Institute of occupational Health, NIOH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sykehuset Telemark HF | Skien | N-3710 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3260798 | Background | Abrons HL, Petersen MR, Sanderson WT, Engelberg AL, Harber P. Symptoms, ventilatory function, and environmental exposures in Portland cement workers. Br J Ind Med. 1988 Jun;45(6):368-75. doi: 10.1136/oem.45.6.368. | |
| 14506344 | Background | Fell AK, Thomassen TR, Kristensen P, Egeland T, Kongerud J. Respiratory symptoms and ventilatory function in workers exposed to portland cement dust. J Occup Environ Med. 2003 Sep;45(9):1008-14. doi: 10.1097/01.jom.0000083036.56116.9d. |
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The individual data is no longer available, due to regulations in Norway requiering individual data to be deleted 5 years after the study was compleeted.
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The workers were required to be off work for at least two days before Medical examinations, then exposed to cement Production dust between 0 and 8 h and again between 24 and 32 h. Those not exposed in these periods were excluded. No unexposed controls were included, the participants were their own controls.
95 workers from two cement plants in Norway (located in the small cities of in Brevik in South-Norway and Kjøpsvik in the North-Norway) were examined in the winter sesons in 2008 and 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exposed Workers | 95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exposed Workers | 95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Lung Function Measurements During One Work Shift (6-8h) | Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity | Posted | Mean | Standard Deviation | Litres | baseline and 6-8h |
|
|
Two weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exposed Workers | 95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Kristin M. Fell, MD, PhD | Telemark Hospital | +4735003106 | annfel@sthf.no |
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| ID | Term |
|---|---|
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Whole blood serum
| Changes in FeNO Measurements Between Baseline (0h) and 32 h |
| 0-32h |
| Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h | 0-32h |
| 10024727 | Background | Ali BA, Ballal SG, Albar AA, Ahmed HO. Post-shift changes in pulmonary function in a cement factory in eastern Saudi Arabia. Occup Med (Lond). 1998 Nov;48(8):519-22. doi: 10.1093/occmed/48.8.519. |
| 17697154 | Background | Larsson K. Aspects on pathophysiological mechanisms in COPD. J Intern Med. 2007 Sep;262(3):311-40. doi: 10.1111/j.1365-2796.2007.01837.x. |
| 16710697 | Background | Raulf-Heimsoth M, Pesch B, Schott K, Kappler M, Preuss R, Marczynski B, Angerer J, Rihs HP, Hahn JU, Merget R, Bruning T. Irritative effects of fumes and aerosols of bitumen on the airways: results of a cross-shift study. Arch Toxicol. 2007 Jan;81(1):35-44. doi: 10.1007/s00204-006-0115-z. Epub 2006 May 19. |
| 16055882 | Background | Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available. |
| 16204605 | Background | Macintyre N, Crapo RO, Viegi G, Johnson DC, van der Grinten CP, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, Gustafsson P, Hankinson J, Jensen R, McKay R, Miller MR, Navajas D, Pedersen OF, Pellegrino R, Wanger J. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J. 2005 Oct;26(4):720-35. doi: 10.1183/09031936.05.00034905. No abstract available. |
| 15817806 | Background | American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| height | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
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| Smoking | Number | participants |
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| duration of exposure | Mean | Standard Deviation | years |
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| Spirometry | Mean | Standard Deviation | Litres |
|
| Fraction of exhaled nitric oxide (FeNO) | Median | Full Range | parts per billion |
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| Inflammatory markers in blood | Median | Full Range | ng/litre |
|
|
| Secondary | Changes in FeNO Measurements During One Shift (6-8h) | Problems With the FeNO (NIOX) device lead to few (58) included in FeNO measurements | Posted | Median | Full Range | ppb | baseline and 6-8h |
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|
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| Secondary | Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h) | Posted | Median | Full Range | ng/Litre | Baseline and 6-8h |
|
|
|
| Secondary | Changes in FeNO Measurements Between Baseline (0h) and 32 h | Posted | Median | Full Range | ppb | 0-32h |
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|
|
| Secondary | Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h | Posted | Median | Full Range | ng/Litre | 0-32h |
|
|
|
| 0 |
| 95 |
| 0 |
| 95 |
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