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Omega-3 Supplementation and Depression Clinical Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01614249
First Posted: June 7, 2012
Last Update Posted: March 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Consortium for Advanced Research Training in Africa (CARTA)
Innovix Pharma Inc.
Information provided by (Responsible Party):
Rose Okoyo Opiyo, University of Nairobi
  Purpose

Fish oil omega-3 supplements provide essential nutrients for brain health and functioning. These nutrients have been proven to be effective in reducing depressive symptoms. They have also been found to be effective and well tolerated in reducing the bad fat accumulation among patients infected with human immunodeficiency virus (HIV)and are using highly active antiretroviral treatment. The role of this nutritional supplement in combating depression among pregnant women who are living with HIV infection has however not been established. Yet, currently, more than 2 million pregnant women are estimated to be living with HIV infection globally. In Kenya, about 9.0% of pregnant women are HIV-seropositive.

In this study, it is hypothesized that there is no difference in the levels of depressive symptoms among HIV infected pregnant women who are taking omega-3 fish oil supplements and those taking a placebo.

The study will therefore seek to ascertain that taking omega-3 fish oil nutritional supplement has a significant positive effect on depressive symptoms among HIV infected pregnant women, compared to a placebo.


Condition Intervention Phase
Depressive Symptoms Dietary Supplement: Soybean oil soft gels Dietary Supplement: Fish oil omega-3 EPA-rich soft gels Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Role of Omega-3 Fish Oil Fatty Acids on Depression Among HIV-seropositive Pregnant Pregnant Women in Nairobi: A Randomized Double-blind Controlled Trial

Resource links provided by NLM:


Further study details as provided by Rose Okoyo Opiyo, University of Nairobi:

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


Enrollment: 216
Study Start Date: June 2012
Study Completion Date: January 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Soybean oil soft gels
Participants on this arm will receive 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.
Dietary Supplement: Soybean oil soft gels
Each participant will receive 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
Other Name: OmegaVia Soybean oil soft gels
Experimental: Fish oil omega-3 EPA-rich soft gels
Participants will receive 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.
Dietary Supplement: Fish oil omega-3 EPA-rich soft gels
A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels will be 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.
Other Name: OmegaVia fish oil omega-3 EPA-rich soft gels

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All pregnant HIV seropositive women with known CD4 cell count less than 500
  • Pregnant women who are in their 2nd trimester of pregnancy (Week 13-27).
  • Normal nutritional status pregnancy with mid-upper arm circumference (MUAC of 22 cm - 33 cm)at entry into the study;
  • Beck Depression Inventory Second Edition (BDI-II) Scale scores at entry into the study of 14 or more;
  • Pregnant HIV positive women who will give consent to participate in the study

Exclusion Criteria:

  • Underweight with MUAC less than 22 cm and overweight with MUAC more than 33 cm at entry into the study;
  • Pregnant women taking antidepressant medications;
  • Those on anti-clotting medication (those with liver disease, varicose veins, peptic ulcers); or Vitamin K supplement. Omega-3 supplements may increase their effects;
  • Those on diabetic medication since Omega-3 may increase their blood sugar.
  • Incomplete depression screening form (more than 5 items unanswered)
  • Those whose BDI-II screening scores are less than 14;
  • Those women currently taking omega-3 nutritional supplement
  • Pregnant HIV-seropositive women without consent to participate in the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614249


Locations
Kenya
Nairobi City Council Health Facilities
Nairobi, Kenya, 020
Sponsors and Collaborators
University of Nairobi
Consortium for Advanced Research Training in Africa (CARTA)
Innovix Pharma Inc.
Investigators
Principal Investigator: Rose O. Opiyo, MSc University of Nairobi
  More Information

Publications:
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Holman RT. The slow discovery of the importance of omega 3 essential fatty acids in human health. J Nutr. 1998 Feb;128(2 Suppl):427S-433S. Review.
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Stoll, A., The Omega-3 connection.2001, New York.: Simon & Schuster.
Lespérance F, Frasure-Smith N, St-André E, Turecki G, Lespérance P, Wisniewski SR. The efficacy of omega-3 supplementation for major depression: a randomized controlled trial. J Clin Psychiatry. 2011 Aug;72(8):1054-62. doi: 10.4088/JCP.10m05966blu. Epub 2010 Jun 15.
Panagiotakos DB, Mamplekou E, Pitsavos C, Kalogeropoulos N, Kastorini CM, Papageorgiou C, Papadimitriou GN, Stefanadis C. Fatty acids intake and depressive symptomatology in a Greek sample: an epidemiological analysis. J Am Coll Nutr. 2010 Dec;29(6):586-94.
Leung BM, Kaplan BJ. Perinatal depression: prevalence, risks, and the nutrition link--a review of the literature. J Am Diet Assoc. 2009 Sep;109(9):1566-75. doi: 10.1016/j.jada.2009.06.368. Review.
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Marcus SM, Flynn HA, Blow FC, Barry KL. Depressive symptoms among pregnant women screened in obstetrics settings. J Womens Health (Larchmt). 2003 May;12(4):373-80.
Bennett HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol. 2004 Apr;103(4):698-709. Review. Erratum in: Obstet Gynecol. 2004 Jun;103(6):1344.
Hornstra G. Essential fatty acids in mothers and their neonates. Am J Clin Nutr. 2000 May;71(5 Suppl):1262S-9S. Review.
Innis SM, Friesen RW. Essential n-3 fatty acids in pregnant women and early visual acuity maturation in term infants. Am J Clin Nutr. 2008 Mar;87(3):548-57.
Melina, V. and B. Davis, The New Becoming Vegetarian. The essential guide to a healthy vegetarian diet. 2003, Tennessee: Healthy Living Publications.
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Gerber JG, Kitch DW, Fichtenbaum CJ, Zackin RA, Charles S, Hogg E, Acosta EP, Connick E, Wohl D, Kojic EM, Benson CA, Aberg JA. Fish oil and fenofibrate for the treatment of hypertriglyceridemia in HIV-infected subjects on antiretroviral therapy: results of ACTG A5186. J Acquir Immune Defic Syndr. 2008 Apr 1;47(4):459-66. Erratum in: J Acquir Immune Defic Syndr. 2009 Mar 1;50(3):343.
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Meydani SN, Lichtenstein AH, Cornwall S, Meydani M, Goldin BR, Rasmussen H, Dinarello CA, Schaefer EJ. Immunologic effects of national cholesterol education panel step-2 diets with and without fish-derived N-3 fatty acid enrichment. J Clin Invest. 1993 Jul;92(1):105-13.
de Luis DA, Bachiller P, Izaola O, Eiros Bouza JM. [Relation between intake of omega 3 fatty acids and CD4 count in patients with HIV infection: a transversal study]. An Med Interna. 2005 Jul;22(7):323-5. Spanish.
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Thase ME. The role of neurobiologic processes in symptoms of depression. J Clin Psychiatry. 2011 Feb;72(2):e08. doi: 10.4088/JCP.9078tx3c.
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Smith Fawzi MC, Kaaya SF, Mbwambo J, Msamanga GI, Antelman G, Wei R, Hunter DJ, Fawzi WW. Multivitamin supplementation in HIV-positive pregnant women: impact on depression and quality of life in a resource-poor setting. HIV Med. 2007 May;8(4):203-12.
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Responsible Party: Rose Okoyo Opiyo, Principal Investigator (PI), 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: March 8, 2016
Last Verified: February 2016

Keywords provided by Rose Okoyo Opiyo, University of Nairobi:
Omega-3
EPA
Depression
HIV infected
Pregnant women

Additional relevant MeSH terms:
Depression
Behavioral Symptoms


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