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Study for Promotion of Health in Recycling Lead (SPHERL)

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ClinicalTrials.gov Identifier: NCT02243904
Recruitment Status : Unknown
Verified May 2017 by Jan A. Staessen, KU Leuven.
Recruitment status was:  Recruiting
First Posted : September 18, 2014
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Jan A. Staessen, KU Leuven

Tracking Information
First Submitted Date September 10, 2014
First Posted Date September 18, 2014
Last Update Posted Date May 11, 2017
Study Start Date August 2015
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 16, 2014)
Annual change in systolic blood pressure as measured by 24-h ambulatory monitoring [ Time Frame: Baseline, 1 year and 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02243904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 16, 2014)
  • Annual change in central hemodynamics [ Time Frame: Baseline, 1 year and 2 years ]
    Annual changes in the central hemodynamics, including aortic blood pressure, the central systolic augmentation index, and aortic pulse wave velocity
  • Annual change in heart function [ Time Frame: Baseline, 1 year and 2 years ]
    Annual changes in ECG-derived indexes
  • Annual change in renal function [ Time Frame: Baseline, 1 year and 2 years ]
    Annual changes in glomerular and tubular renal function measured on a continuous scale and the incidence of renal dysfunction
  • Annual change in autonomic nervous function [ Time Frame: Baseline, 1 year and 2 years ]
    Annual changes in alterations in the autonomic nervous cardiovascular modulation, as assessed by heart rate variability
  • Annual change in peripheral nervous conduction velocity [ Time Frame: Baseline, 1 year and 2 years ]
    Annual changes in nerve conduction velocity
  • Annual change in neurocognitive performance [ Time Frame: Baseline, 1 year and 2 years ]
    Annual changes in neurocognitive testing
  • Annual change in quality of life [ Time Frame: Baseline, 1 year and 2 years ]
    Annual changes in self-assessed quality of life
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study for Promotion of Health in Recycling Lead
Official Title Study for Promotion of Health in Recycling Lead
Brief Summary

Study for Promotion of Health in Recycling Lead (SPHERL) is a prospective 2-year follow-up study of lead workers with exposure levels varying between and within individuals. SPHERL addresses to what extent between-subject differences or within-subject changes in lead exposure may have a measurable impact on blood pressure, the cardiovascular system, renal function, the autonomic nervous system, peripheral nervous conduction velocity, and neurocognitive function.

At the beginning of December 2015, 70 participants were included in the study.

Detailed Description

Background

  • Whether low-level lead exposure impacts on blood pressure, regulation of the cardiovascular system, glomerular or tubular renal function, sympathetic nervous modulation, peripheral nervous conduction velocity, and neurocognitive function remains uncertain.

Study Population

  • SPHERL will enroll 500 lead recycling workers with changing lead exposure, who will be examined at baseline (2014-2015) and followed up at annual intervals for 2 years (2016-2017).

Methods

  • Volunteers eligible for the study are (i) new and existing hires without previous occupational lead exposure who will be performing tasks with or without occupational lead exposure and (ii) existing hires with occupational lead exposure who will be transitioning to job tasks without occupational lead exposure within the next 2 years.
  • Blood lead concentration will be the main biomarker of exposure.
  • The main outcome variables are (i) blood pressure measured conventionally and by ambulatory monitoring, and analyzed as continuous or categorical variable, both cross-sectionally and longitudinally; (ii) indexes of glomerular and tubular renal function, (iii) heart rate variability analyzed in the frequency domain as measure of autonomous sympathetic modulation, (iv) peripheral nerve conductivity, (v) neurocognitive performance, (vi) and quality of life [the EuroQOL five dimensions (EQ-5D) questionnaire].

Expected Outcomes

  • Assuming a 4-fold or higher surge in the blood lead concentration, the study is powered to demonstrate over 2 years an acceleration in the age-related rise of systolic blood pressure by 1 to 4 mm Hg or an increase of the coefficient of multiple determination (R2) from 0.22 to 0.24 by adding the change in the blood lead concentration to models relating changes in blood pressure to three other covariables. The longitudinal design of our study complies with the temporality principle of the Bradford-Hill criteria for assessing possible causality between outcomes and exposure.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be recruited among the work force employed at lead recycling plants in North America.
Condition Occupational Exposure
Intervention Not Provided
Study Groups/Cohorts Lead exposure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 16, 2014)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2018
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women and men are eligible.
  • New hires without previous occupational lead exposure who will be performing tasks with lead exposure or current employees without previous occupational lead exposure moving to tasks with exposure.
  • Informed written consent.

Exclusion Criteria:

  • Pregnancy.
  • Any serious health condition.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02243904
Other Study ID Numbers SPHERL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jan A. Staessen, KU Leuven
Study Sponsor KU Leuven
Collaborators Not Provided
Investigators
Principal Investigator: Jan A Staessen, MD, PhD University of Leuven
PRS Account KU Leuven
Verification Date May 2017