Trial Outcomes & Findings for Feasibility Study of Omega-3 Fatty Acids in Dialysis Patients (NCT NCT01002118)
NCT ID: NCT01002118
Last Updated: 2017-08-09
Results Overview
Determine recruitment by number eligible/number enrolled
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
4 months
Results posted on
2017-08-09
Participant Flow
Participant milestones
| Measure |
Omega-3 Fatty Acid
Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
Randomized Only Patient
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Omega-3 Fatty Acid
n=1 Participants
Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
|
Holter monitor
|
1 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 4 monthsDetermine recruitment by number eligible/number enrolled
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=1 Participants
Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
|
|---|---|
|
Determine Recruitment Rates
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 monthspercent of subjects with significant arrhythmia present on Holter electrocardiography
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=1 Participants
Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
|
|---|---|
|
Assess the Effectiveness of Omega-3 Fatty Acid Compared to Placebo on Electrocardiographic Parameters.
|
0 percentage of Holter montiors obtained
|
SECONDARY outcome
Timeframe: 4 monthspercent of pills taken each month calculated as number of pills taken/number of pills dispensed
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=1 Participants
Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
|
|---|---|
|
Medication Adherence
|
100 percentage of pills
|
Adverse Events
Omega-3 Fatty Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place