Trial Outcomes & Findings for Omega-3 Supplementation and Depression Clinical Trial (NCT NCT01614249)
NCT ID: NCT01614249
Last Updated: 2018-06-28
Results Overview
Depressive symptoms were assessed by Beck Depression Inventory Second Edition (BDI-II) Scoring scale at Baseline and end of study during the 8- week study period. The BDI-II Scale is a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe).Scores for each symptom are added up to obtain the total scores for all 21 items, which are interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression. The change in BDI-II scores were computed from post-intervention scores at week 8 and baseline BDI-II scores at week 0.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
216 participants
Primary outcome timeframe
8 weeks
Results posted on
2018-06-28
Participant Flow
Women who met the trial inclusion criteria were recruited from clinic registers at their respective Prevention of mother-to-child transmission program clinics from July 2012 to May 2013 with assistance from mentor-mothers in the clinics. Women visiting the clinics first time were included in clinic registers and invited to participate in the trial.
Participants were assigned to either of the trial arms soon after enrollment to minimize drop-outs which might have occurred if enrolled participants exceeded gestation age or gave birth before randomization.
Participant milestones
| Measure |
Soybean Oil Soft Gels Control Group
As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.
|
Fish Oil Omega-3 EPA-rich Experimental Group
As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
109
|
|
Overall Study
At Week-4
|
98
|
92
|
|
Overall Study
At Week-8 (End of Study Period)
|
96
|
86
|
|
Overall Study
COMPLETED
|
96
|
86
|
|
Overall Study
NOT COMPLETED
|
11
|
23
|
Reasons for withdrawal
| Measure |
Soybean Oil Soft Gels Control Group
As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.
|
Fish Oil Omega-3 EPA-rich Experimental Group
As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
23
|
Baseline Characteristics
Omega-3 Supplementation and Depression Clinical Trial
Baseline characteristics by cohort
| Measure |
Soybean Oil Soft Gels Control Group
n=107 Participants
As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.
|
Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group
n=109 Participants
As the intervention group, participants received a dietary supplement of Omega Via fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits to resupply the soft-gels, monitoring of side effects and compliance and data collection.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Each participants took three soft gels of fish oil omega-3 fatty acid per day, each containing more EPA (0.715 grams) than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
102 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26 Years
n=5 Participants
|
26 Years
n=7 Participants
|
26 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
107 participants
n=5 Participants
|
109 participants
n=7 Participants
|
216 participants
n=5 Participants
|
|
Gestation age
|
22 Weeks
n=5 Participants
|
22 Weeks
n=7 Participants
|
22 Weeks
n=5 Participants
|
|
Cluster of differentiation 4 (CD4) cell count
|
360 cells/µl
n=5 Participants
|
361 cells/µl
n=7 Participants
|
360 cells/µl
n=5 Participants
|
|
Mid-upper-arm circumference (MUAC)
|
26.0 cm
n=5 Participants
|
26.0 cm
n=7 Participants
|
26.0 cm
n=5 Participants
|
|
BDI-II depressive symptom scores
|
21 Scores on a scale
n=5 Participants
|
20 Scores on a scale
n=7 Participants
|
21 Scores on a scale
n=5 Participants
|
|
Marital status
Single (not married, divorced, widowed
|
22 participants
n=5 Participants
|
27 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Marital status
Married
|
85 participants
n=5 Participants
|
82 participants
n=7 Participants
|
167 participants
n=5 Participants
|
|
Parity
First pregnancy
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Parity
Not first pregnancy
|
83 participants
n=5 Participants
|
85 participants
n=7 Participants
|
168 participants
n=5 Participants
|
|
Education status
No High school education
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
110 participants
n=5 Participants
|
|
Education status
At least High school education
|
52 participants
n=5 Participants
|
54 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Employment status
Not in gainful employment
|
64 participants
n=5 Participants
|
61 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Employment status
In gainful employment with income
|
43 participants
n=5 Participants
|
48 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Household income per month
|
5025 Kenya Shillings (Ksh.)
n=5 Participants
|
6000 Kenya Shillings (Ksh.)
n=7 Participants
|
5050 Kenya Shillings (Ksh.)
n=5 Participants
|
|
HIV status knowledge before pregnancy
No, newly tested less than 6 months
|
56 participants
n=5 Participants
|
56 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
HIV status knowledge before pregnancy
Yes, known positive, 6 months plus
|
51 participants
n=5 Participants
|
53 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
HIV status disclosure to anyone
Not disclosed
|
25 participants
n=5 Participants
|
18 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
HIV status disclosure to anyone
Disclosed to someone
|
82 participants
n=5 Participants
|
91 participants
n=7 Participants
|
173 participants
n=5 Participants
|
|
prevention of mother-to-child transmission program m2m support group meeting attendance
Not attended
|
54 participants
n=5 Participants
|
62 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
prevention of mother-to-child transmission program m2m support group meeting attendance
Attended
|
53 participants
n=5 Participants
|
47 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Experienced stressful life event
None 2 weeks before study
|
75 participants
n=5 Participants
|
73 participants
n=7 Participants
|
148 participants
n=5 Participants
|
|
Experienced stressful life event
Yes, 2 weeks before study
|
32 participants
n=5 Participants
|
36 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Dietary vitamin C
Below Estimated Average Requirement (EAR)
|
59 participants
n=5 Participants
|
62 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Dietary vitamin C
At least EAR for pregnant women
|
48 participants
n=5 Participants
|
47 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Dietary vitamin B1
Below Estimated Average Requirement (EAR)
|
67 participants
n=5 Participants
|
73 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Dietary vitamin B1
At least EAR for pregnant women
|
40 participants
n=5 Participants
|
36 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Dietary vitamin B6
Below Estimated Average Requirement (EAR)
|
87 participants
n=5 Participants
|
85 participants
n=7 Participants
|
172 participants
n=5 Participants
|
|
Dietary vitamin B6
At least EAR for pregnant women
|
20 participants
n=5 Participants
|
24 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Dietary vitamin B12
Below Estimated Average Requirement (EAR)
|
94 participants
n=5 Participants
|
97 participants
n=7 Participants
|
191 participants
n=5 Participants
|
|
Dietary vitamin B12
At least EAR for pregnant women
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Dietary folate
Below Estimated Average Requirement (EAR)
|
91 participants
n=5 Participants
|
98 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
Dietary folate
At least EAR for pregnant women
|
16 participants
n=5 Participants
|
11 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Dietary Iron
Below Estimated Average Requirement (EAR)
|
107 participants
n=5 Participants
|
109 participants
n=7 Participants
|
216 participants
n=5 Participants
|
|
Dietary Iron
At least EAR for pregnant women
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Dietary vitamin E
Below Estimated Average Requirement (EAR)
|
87 participants
n=5 Participants
|
89 participants
n=7 Participants
|
176 participants
n=5 Participants
|
|
Dietary vitamin E
At least EAR for pregnant women
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Dietary calcium
Below Estimated Average Requirement (EAR)
|
79 participants
n=5 Participants
|
78 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
Dietary calcium
At least EAR for pregnant women
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Dietary selenium
Below Estimated Average Requirement (EAR)
|
76 participants
n=5 Participants
|
82 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
Dietary selenium
At least EAR for pregnant women
|
31 participants
n=5 Participants
|
27 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Dietary zinc
Below Estimated Average Requirement (EAR)
|
105 participants
n=5 Participants
|
109 participants
n=7 Participants
|
214 participants
n=5 Participants
|
|
Dietary zinc
At least EAR for pregnant women
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Dietary total omega-3
Below Recommended daily intake
|
89 participants
n=5 Participants
|
99 participants
n=7 Participants
|
188 participants
n=5 Participants
|
|
Dietary total omega-3
At least recommended daily intake
|
18 participants
n=5 Participants
|
10 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Only participants who completed the 8-weeks trial period were included in the final analysis of primary outcome. Per protocol analysis Post-intervention BDI-II scores at week 8 minus baseline BDI-II scores at week 0
Depressive symptoms were assessed by Beck Depression Inventory Second Edition (BDI-II) Scoring scale at Baseline and end of study during the 8- week study period. The BDI-II Scale is a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe).Scores for each symptom are added up to obtain the total scores for all 21 items, which are interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression. The change in BDI-II scores were computed from post-intervention scores at week 8 and baseline BDI-II scores at week 0.
Outcome measures
| Measure |
Soybean Oil Soft Gels Control Group
n=96 Participants
As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.
|
Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group
n=86 Participants
As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.
|
|---|---|---|
|
Change in BDI-II Depressive Symptom Scores
|
-13.9 scores on BDI-II scale
Interval -15.3 to -12.6
|
-13.3 scores on BDI-II scale
Interval -14.9 to -12.0
|
Adverse Events
Soybean Oil Soft Gels
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Fish Oil Omega-3 EPA-rich Soft Gels
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Soybean Oil Soft Gels
n=107 participants at risk
Participants on this arm received a dietary supplement of OmegaVia soybean oil soft gels as a placebo for 8 weeks with bi-weekly follow-up visits to monitor side effects and compliance.
Soybean oil soft gels: Each participant received OmegaVia soybean oil soft gels to take orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.
|
Fish Oil Omega-3 EPA-rich Soft Gels
n=109 participants at risk
Participants received OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight (8) weeks with bi-weekly follow-up visits for monitoring of side effects and compliance and data collection.
Fish oil omega-3 EPA-rich soft gels: A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels was taken orally per day as one soft gel in the morning, mid-day and evening after meals for 8 weeks with bi-weekly follow-up visits.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea with fishy-after-taste
|
4.7%
5/107 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
9.2%
10/109 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
|
Gastrointestinal disorders
Occasional vomitting in the morning after taking soft gel
|
2.8%
3/107 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
5.5%
6/109 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
|
Gastrointestinal disorders
Occasional heartburn
|
4.7%
5/107 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
2.8%
3/109 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
|
Gastrointestinal disorders
Occasional bloated stomach
|
0.00%
0/107 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
1.8%
2/109 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
|
Gastrointestinal disorders
Occasional loose stool
|
0.93%
1/107 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
0.00%
0/109 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
|
Skin and subcutaneous tissue disorders
Occasional itchy skin
|
0.93%
1/107 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
1.8%
2/109 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
|
Blood and lymphatic system disorders
Nose Bleeding once
|
0.00%
0/107 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
0.92%
1/109 • Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place