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Omega-3 Supplementation and Depression Clinical Trial

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ClinicalTrials.gov Identifier: NCT01614249
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : March 8, 2016
Last Update Posted : June 28, 2018
Sponsor:
Collaborators:
Consortium for Advanced Research Training in Africa (CARTA)
Innovix Pharma Inc.
Information provided by (Responsible Party):
Rose Okoyo Opiyo, University of Nairobi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Depressive Symptoms
Interventions Dietary Supplement: Soybean oil soft gels
Dietary Supplement: Fish oil omega-3 EPA-rich soft gels
Enrollment 216

Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Soybean Oil Soft Gels Control Group Fish Oil Omega-3 EPA-rich Experimental Group
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 107 [1] 109 [2]
At Week-4 98 [2] 92 [2]
At Week-8 (End of Study Period) 96 [3] 86 [3]
Completed 96 [4] 86 [4]
Not Completed 11 23
Reason Not Completed
Lost to Follow-up             11             23
[1]
Participants received every two-weeks supply and monitored regularly on cell-phone and face-to-face.
[2]
Participants received every two-week supply and monitored regularly on cell-phone and face-to-face.
[3]
End of study data collected for all participants who completed the 8-week trial period.
[4]
End of study data analyzed for only participants who completed the 8-week trial period.
Arm/Group Title Soybean Oil Soft Gels Control Group Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 107 109 216
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
<=18 years
5
   4.7%
5
   4.6%
10
   4.6%
Between 18 and 65 years
102
  95.3%
104
  95.4%
206
  95.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 107 participants 109 participants 216 participants
26
(22 to 30)
26
(22 to 30)
26
(22 to 30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Female
107
 100.0%
109
 100.0%
216
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Kenya Number Analyzed 107 participants 109 participants 216 participants
107 109 216
Gestation age  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 107 participants 109 participants 216 participants
22
(19 to 24)
22
(18 to 24)
22
(18 to 24)
Cluster of differentiation 4 (CD4) cell count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/µl
Number Analyzed 107 participants 109 participants 216 participants
360
(288 to 414)
361
(287 to 440)
360
(288 to 425)
Mid-upper-arm circumference (MUAC)  
Median (Inter-Quartile Range)
Unit of measure:  Cm
Number Analyzed 107 participants 109 participants 216 participants
26.0
(24.3 to 28.0)
26.0
(23.9 to 27.6)
26.0
(24.0 to 27.8)
BDI-II depressive symptom scores   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Scores on a scale
Number Analyzed 107 participants 109 participants 216 participants
21
(17 to 25)
20
(16 to 25)
21
(17 to 25)
[1]
Measure Description: Beck Depression Inventory Second Edition (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.
Marital status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Single (not married, divorced, widowed 22 27 49
Married 85 82 167
Parity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
First pregnancy 24 24 48
Not first pregnancy 83 85 168
Education status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
No High school education 55 55 110
At least High school education 52 54 106
Employment status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Not in gainful employment 64 61 125
In gainful employment with income 43 48 91
Household income per month  
Median (Inter-Quartile Range)
Unit of measure:  Kenya Shillings (Ksh.)
Number Analyzed 107 participants 109 participants 216 participants
5025
(3000 to 8000)
6000
(3000 to 8000)
5050
(3000 to 8000)
HIV status knowledge before pregnancy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
No, newly tested less than 6 months 56 56 112
Yes, known positive, 6 months plus 51 53 104
HIV status disclosure to anyone  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Not disclosed 25 18 43
Disclosed to someone 82 91 173
prevention of mother-to-child transmission program m2m support group meeting attendance  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Not attended 54 62 116
Attended 53 47 100
Experienced stressful life event  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
None 2 weeks before study 75 73 148
Yes, 2 weeks before study 32 36 68
Dietary vitamin C  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Below Estimated Average Requirement (EAR) 59 62 121
At least EAR for pregnant women 48 47 95
Dietary vitamin B1  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Below Estimated Average Requirement (EAR) 67 73 140
At least EAR for pregnant women 40 36 76
Dietary vitamin B6  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Below Estimated Average Requirement (EAR) 87 85 172
At least EAR for pregnant women 20 24 44
Dietary vitamin B12  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Below Estimated Average Requirement (EAR) 94 97 191
At least EAR for pregnant women 13 12 25
Dietary folate  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Below Estimated Average Requirement (EAR) 91 98 189
At least EAR for pregnant women 16 11 27
Dietary Iron  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Below Estimated Average Requirement (EAR) 107 109 216
At least EAR for pregnant women 0 0 0
Dietary vitamin E  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Below Estimated Average Requirement (EAR) 87 89 176
At least EAR for pregnant women 20 20 40
Dietary calcium  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Below Estimated Average Requirement (EAR) 79 78 157
At least EAR for pregnant women 28 31 59
Dietary selenium  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Below Estimated Average Requirement (EAR) 76 82 158
At least EAR for pregnant women 31 27 58
Dietary zinc  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Below Estimated Average Requirement (EAR) 105 109 214
At least EAR for pregnant women 2 0 2
Dietary total omega-3  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Below Recommended daily intake 89 99 188
At least recommended daily intake 18 10 28
1.Primary Outcome
Title Change in BDI-II Depressive Symptom Scores
Hide Description 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.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Soybean Oil Soft Gels Control Group Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 96 86
Mean (95% Confidence Interval)
Unit of Measure: scores on BDI-II scale
-13.9
(-15.3 to -12.6)
-13.3
(-14.9 to -12.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Soybean Oil Soft Gels Control Group, Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group
Comments Null hypothesis: There is no difference in the magnitude of change in BDI-II scores between HIV–seropositive pregnant women on fish oil omega-3 EPA-rich supplements and the control group on soybean oil soft gels. A sample size of 91 women per arm gave an 85% power to detect as statistically significant at 5% level, a true difference of 4 scores in the mean depressive symptom scores between the two arms assuming a within group standard deviation of nine in depressive symptom scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments The p-value was adjusted for baseline variations in the analysis of covariance (ANCOVA) regression model. The significance level was set at p-value less than 0.05.
Method ANCOVA
Comments In ANCOVA, fish oil group was main effect, participant baseline variables were covariates and presence of interaction between covariates was tested.
Method of Estimation Estimation Parameter Slope
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
-0.58 to 2.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.80
Estimation Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Soybean Oil Soft Gels Fish Oil Omega-3 EPA-rich Soft Gels
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Soybean Oil Soft Gels Fish Oil Omega-3 EPA-rich Soft Gels
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Soybean Oil Soft Gels Fish Oil Omega-3 EPA-rich Soft Gels
Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   0/109 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Soybean Oil Soft Gels Fish Oil Omega-3 EPA-rich Soft Gels
Affected / at Risk (%) Affected / at Risk (%)
Total   15/107 (14.02%)   24/109 (22.02%) 
Blood and lymphatic system disorders     
Nose Bleeding once  [1]  0/107 (0.00%)  1/109 (0.92%) 
Gastrointestinal disorders     
Nausea with fishy-after-taste  [2]  5/107 (4.67%)  10/109 (9.17%) 
Occasional vomitting in the morning after taking soft gel  [2]  3/107 (2.80%)  6/109 (5.50%) 
Occasional heartburn  [2]  5/107 (4.67%)  3/109 (2.75%) 
Occasional bloated stomach  [2]  0/107 (0.00%)  2/109 (1.83%) 
Occasional loose stool  [2]  1/107 (0.93%)  0/109 (0.00%) 
Skin and subcutaneous tissue disorders     
Occasional itchy skin  [2]  1/107 (0.93%)  2/109 (1.83%) 
Indicates events were collected by systematic assessment
[1]
This was reported only once by one participant. Data was collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
[2]
Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Omega-3 intake value based on international database due to absence in local food composition database. Cellular level EPA/DHA not reported due to technical problems with collected samples.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Mrs. Rose Okoyo Opiyo
Organization: University of Nairobi
Phone: +254 020 2726300 ext 43481
Publications:
Jones, P. and A. Papamandjaris, eds. Lipid: Cellular Metabolism in Present Knowledge in Nutrition. 8th ed. Present Knowledge in Nutrition, ed. B. Bowman and R. Russell2001, ILSI Press: Washington, DC. 104-114.
Stoll, A., The Omega-3 connection.2001, New York.: Simon & Schuster.
WHO/UNAIDS/UNICEF, Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector. Progress Report, April 2007., 2007.
Melina, V. and B. Davis, The New Becoming Vegetarian. The essential guide to a healthy vegetarian diet. 2003, Tennessee: Healthy Living Publications.
NASCOP, Kenya AIDS Indicator Survey, (KAIS) 2007, 2009, NASCOP: Nairobi. p. 11.
KNBS, Kenya 2009 Population and Housing Census, M.o.P.a.N. Development, Editor 2010, Government Printers: Nairobi.
NASCOP/MOH/CDC, Sentinel Surveillance of HIV & STDs in Kenya Report 2006, 2006, NASCOP: Nairobi.
Responsible Party: Rose Okoyo Opiyo, University of Nairobi
ClinicalTrials.gov Identifier: NCT01614249     History of Changes
Other Study ID Numbers: ODR-2011/2012
ECCT/12/03/01 ( Registry Identifier: Pharmacy and Poisons Board, Kenya )
First Submitted: June 5, 2012
First Posted: June 7, 2012
Results First Submitted: November 25, 2015
Results First Posted: March 8, 2016
Last Update Posted: June 28, 2018