Trial Outcomes & Findings for Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama (NCT NCT01261338)

Last Updated: 2020-09-14

Results Overview

The outcome is the percent change in body burden of total PCB's measured over one year. Initially the percent of baseline is calculated as (value at one year / value at baseline) \*100, then this is examined modeling over time as compared to the 100% at baseline.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

28 participants

Primary outcome timeframe

one year

Results posted on

2020-09-14

Participant Flow

Twenty-eight participants were recruited prior to April 2011.

Participants were randomized into groups of 14 each, to receive either olestra and vegetable oil.

Participant milestones

Participant milestones
Measure	Olestra Non-absorbable fat olestra : non-absorbable dietary fat	Vegetable Oil absorbable fat
Overall Study STARTED	14	14
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Olestra Non-absorbable fat olestra : non-absorbable dietary fat	Vegetable Oil absorbable fat
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olestra n=14 Participants Non-absorbable fat olestra : non-absorbable dietary fat	Vegetable Oil n=14 Participants absorbable fat	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=99 Participants	11 Participants n=107 Participants	20 Participants n=206 Participants
Age, Categorical >=65 years	5 Participants n=99 Participants	3 Participants n=107 Participants	8 Participants n=206 Participants
Age, Continuous	59.9 years STANDARD_DEVIATION 9.6 • n=99 Participants	61.0 years STANDARD_DEVIATION 5.7 • n=107 Participants	60.6 years STANDARD_DEVIATION 7.8 • n=206 Participants
Sex: Female, Male Female	8 Participants n=99 Participants	9 Participants n=107 Participants	17 Participants n=206 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants
Region of Enrollment United States	14 participants n=99 Participants	14 participants n=107 Participants	28 participants n=206 Participants

PRIMARY outcome

Timeframe: one year

Population: Per protocol, based on elevated PCB levels

Outcome measures

Outcome measures
Measure	Olestra n=11 Participants Non-absorbable fat olestra : non-absorbable dietary fat	Vegetable Oil n=12 Participants absorbable fat
Percent Change From Baseline for Total PCB Levels	92 % of baseline total PCBs Standard Error 3.4	96 % of baseline total PCBs Standard Error 4.3

PRIMARY outcome

Timeframe: One year

Population: All participants who completed the trial were analyzed.

This is a measure of the change in body burden of PCBs

Outcome measures

Outcome measures
Measure	Olestra n=11 Participants Non-absorbable fat olestra : non-absorbable dietary fat	Vegetable Oil n=12 Participants absorbable fat
Rate of Change of Lipid Adjusted PCB Levels	-0.0829 ng/g lipid/year Standard Error 0.0357	-0.0413 ng/g lipid/year Standard Error 0.0408

Adverse Events

Olestra

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Vegetable Oil

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Olestra n=14 participants at risk Non-absorbable fat olestra : non-absorbable dietary fat	Vegetable Oil n=14 participants at risk absorbable fat
Cardiac disorders Hospitalized for heart catheter	7.1% 1/14 • Number of events 1 • 1 year	0.00% 0/14 • 1 year
Gastrointestinal disorders Bleeding Ulcers	0.00% 0/14 • 1 year	7.1% 1/14 • Number of events 1 • 1 year
Cardiac disorders Chest pain and palpitations	0.00% 0/14 • 1 year	7.1% 1/14 • Number of events 1 • 1 year
Cardiac disorders Heart stent replacement	7.1% 1/14 • Number of events 1 • 1 year	— 0/0 • 1 year

Other adverse events

Other adverse events
Measure	Olestra n=14 participants at risk Non-absorbable fat olestra : non-absorbable dietary fat	Vegetable Oil n=14 participants at risk absorbable fat
Gastrointestinal disorders Diarrhea	14.3% 2/14 • Number of events 3 • 1 year	14.3% 2/14 • Number of events 4 • 1 year
General disorders Cold	7.1% 1/14 • Number of events 1 • 1 year	0.00% 0/14 • 1 year
Skin and subcutaneous tissue disorders Rash on body	7.1% 1/14 • Number of events 1 • 1 year	14.3% 2/14 • Number of events 2 • 1 year
Cardiac disorders Irregular heartbeat	0.00% 0/14 • 1 year	7.1% 1/14 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Pain in right hip	0.00% 0/14 • 1 year	7.1% 1/14 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Rash on left and right anticubital area	0.00% 0/14 • 1 year	7.1% 1/14 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Infection in lining of rib cage	0.00% 0/14 • 1 year	7.1% 1/14 • Number of events 1 • 1 year
Gastrointestinal disorders Indigestion	7.1% 1/14 • Number of events 1 • 1 year	0.00% 0/14 • 1 year
Blood and lymphatic system disorders Gout	7.1% 1/14 • Number of events 1 • 1 year	0.00% 0/14 • 1 year
Infections and infestations Sinus infection	7.1% 1/14 • Number of events 1 • 1 year	0.00% 0/14 • 1 year
Infections and infestations Yeast Infection	7.1% 1/14 • Number of events 1 • 1 year	0.00% 0/14 • 1 year
Endocrine disorders HGA1C elevated 6.4%	7.1% 1/14 • Number of events 1 • 1 year	0.00% 0/14 • 1 year
General disorders Cough	0.00% 0/14 • 1 year	7.1% 1/14 • Number of events 1 • 1 year

Additional Information

Ronald J. Jandacek, PhD, Principal Investigator

University of Cincinnati

Phone: 513-558-5492

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place