Omega-3 Supplementation and Depression Clinical Trial

This study has been completed.
Sponsor:
Collaborators:
Consortium for Advanced Research Training in Africa (CARTA)
Innovix Pharma Inc.
Information provided by (Responsible Party):
Rose Okoyo Opiyo, University of Nairobi
ClinicalTrials.gov Identifier:
NCT01614249
First received: June 5, 2012
Last updated: February 9, 2016
Last verified: February 2016
Results First Received: November 25, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Soybean Oil Soft Gels Control Group     Fish Oil Omega-3 EPA-rich Experimental Group  
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  
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 Soft Gels Experimental Group

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 Total of all reporting groups

Baseline Measures
    Soybean Oil Soft Gels Control Group     Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group     Total  
Number of Participants  
[units: participants]
  107     109     216  
Age  
[units: participants]
     
<=18 years     5     5     10  
Between 18 and 65 years     102     104     206  
>=65 years     0     0     0  
Age  
[units: Years]
Median (Inter-Quartile Range)
  26   (22 to 30)     26   (22 to 30)     26   (22 to 30)  
Gender  
[units: participants]
     
Female     107     109     216  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Kenya     107     109     216  
Gestation age  
[units: Weeks]
Median (Inter-Quartile Range)
  22   (19 to 24)     22   (18 to 24)     22   (18 to 24)  
Cluster of differentiation 4 (CD4) cell count  
[units: cells/µl]
Median (Inter-Quartile Range)
  360   (288 to 414)     361   (287 to 440)     360   (288 to 425)  
Mid-upper-arm circumference (MUAC)  
[units: cm]
Median (Inter-Quartile Range)
  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]
[units: Scores on a scale]
Median (Inter-Quartile Range)
  21   (17 to 25)     20   (16 to 25)     21   (17 to 25)  
Marital status  
[units: participants]
     
Single (not married, divorced, widowed     22     27     49  
Married     85     82     167  
Parity  
[units: participants]
     
First pregnancy     24     24     48  
Not first pregnancy     83     85     168  
Education status  
[units: participants]
     
No High school education     55     55     110  
At least High school education     52     54     106  
Employment status  
[units: participants]
     
Not in gainful employment     64     61     125  
In gainful employment with income     43     48     91  
Household income per month  
[units: Kenya Shillings (Ksh.)]
Median (Inter-Quartile Range)
  5025   (3000 to 8000)     6000   (3000 to 8000)     5050   (3000 to 8000)  
HIV status knowledge before pregnancy  
[units: 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  
[units: participants]
     
Not disclosed     25     18     43  
Disclosed to someone     82     91     173  
prevention of mother-to-child transmission program m2m support group meeting attendance  
[units: participants]
     
Not attended     54     62     116  
Attended     53     47     100  
Experienced stressful life event  
[units: participants]
     
None 2 weeks before study     75     73     148  
Yes, 2 weeks before study     32     36     68  
Dietary vitamin C  
[units: participants]
     
Below Estimated Average Requirement (EAR)     59     62     121  
At least EAR for pregnant women     48     47     95  
Dietary vitamin B1  
[units: participants]
     
Below Estimated Average Requirement (EAR)     67     73     140  
At least EAR for pregnant women     40     36     76  
Dietary vitamin B6  
[units: participants]
     
Below Estimated Average Requirement (EAR)     87     85     172  
At least EAR for pregnant women     20     24     44  
Dietary vitamin B12  
[units: participants]
     
Below Estimated Average Requirement (EAR)     94     97     191  
At least EAR for pregnant women     13     12     25  
Dietary folate  
[units: participants]
     
Below Estimated Average Requirement (EAR)     91     98     189  
At least EAR for pregnant women     16     11     27  
Dietary Iron  
[units: participants]
     
Below Estimated Average Requirement (EAR)     107     109     216  
At least EAR for pregnant women     0     0     0  
Dietary vitamin E  
[units: participants]
     
Below Estimated Average Requirement (EAR)     87     89     176  
At least EAR for pregnant women     20     20     40  
Dietary calcium  
[units: participants]
     
Below Estimated Average Requirement (EAR)     79     78     157  
At least EAR for pregnant women     28     31     59  
Dietary selenium  
[units: participants]
     
Below Estimated Average Requirement (EAR)     76     82     158  
At least EAR for pregnant women     31     27     58  
Dietary zinc  
[units: participants]
     
Below Estimated Average Requirement (EAR)     105     109     214  
At least EAR for pregnant women     2     0     2  
Dietary total omega-3  
[units: participants]
     
Below Recommended daily intake     89     99     188  
At least recommended daily intake     18     10     28  
[1] 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.



  Outcome Measures

1.  Primary:   Change in BDI-II Depressive Symptom Scores   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: roseopiyo@uonbi.ac.ke


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 )
Study First Received: June 5, 2012
Results First Received: November 25, 2015
Last Updated: February 9, 2016
Health Authority: Kenya: Pharmacy and Poisons Board