Trial Outcomes & Findings for Effect of Omega-3 Fatty Acid on Vitamin D Activation (NCT NCT01596842)

NCT ID: NCT01596842

Last Updated: 2015-03-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2015-03-10

Participant Flow

Participant milestones

Measure	Omega-3 Fatty Acid Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks cholecalciferol: if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks	Olive Oil Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks cholecalciferol: if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks
Overall Study STARTED	10	7
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Omega-3 Fatty Acid on Vitamin D Activation

Baseline characteristics by cohort

Measure	Omega-3 Fatty Acid n=8 Participants Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks cholecalciferol: if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks	Olive Oil n=7 Participants Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks cholecalciferol: if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks	Total n=15 Participants Total of all reporting groups
Age, Continuous	60.0 years STANDARD_DEVIATION 7.3 • n=113 Participants	64.4 years STANDARD_DEVIATION 8.5 • n=163 Participants	62.1 years STANDARD_DEVIATION 7.9 • n=160 Participants
Sex: Female, Male Female	6 Participants n=113 Participants	4 Participants n=163 Participants	10 Participants n=160 Participants
Sex: Female, Male Male	2 Participants n=113 Participants	3 Participants n=163 Participants	5 Participants n=160 Participants
Region of Enrollment Korea, Republic of	8 participants n=113 Participants	7 participants n=163 Participants	15 participants n=160 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Omega-3 Fatty Acid n=8 Participants Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks cholecalciferol: if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks	Olive Oil n=7 Participants Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks cholecalciferol: if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks
25-hydroxyvitamin D Levels at 12 Weeks	44.4 ng/ml Standard Deviation 10.8	48.9 ng/ml Standard Deviation 5.8

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Omega-3 Fatty Acid n=8 Participants Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks cholecalciferol: if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks	Olive Oil n=7 Participants Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks cholecalciferol: if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks
Hemoglobin Levels at 12 Weeks	10.3 g/dL Standard Deviation 0.7	11 g/dL Standard Deviation 1.1

SECONDARY outcome

Timeframe: 4 weeks, 8 weeks and 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks, 8 weeks and 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks, 8 weeks and 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks, 8 weeks and 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

Omega-3 Fatty Acid

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Olive Oil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Omega-3 Fatty Acid n=10 participants at risk Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks cholecalciferol: if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks	Olive Oil n=7 participants at risk Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks cholecalciferol: if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks
Reproductive system and breast disorders vaginal spotting	10.0% 1/10 • Number of events 1	0.00% 0/7

Additional Information

Professor

Dong-A University

Phone: 82-51-240-2811

Email: anws@dau.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place