EAL

MIP: Omega-3

Author and Year:

Mozurkewich E, Clinton C et al, 2013

PubMed ID:

Article Title:

The Mothers, Omega-3, and Mental Health Study: a double-blind, randomized controlled trial.

Authors:

Mozurkewich E, Clinton C, Chilimigras J, Hamilton S, Allbaugh L, Berman D, Marcus S, Romero V, Treadwell M, Keeton K, Vahratian A, Schrader R, Ren J, Djuric Z

Journal:

American Journal of Obstetrics and Gynecology

Year of publication:

2013

Volume:

208

Issue:

Page numbers:

313.e1-313.e9

Study Design:

Randomized Controlled Trial

Risk of Bias Assessment Rating:

Positive

Inclusion Criteria:

Inclusion criteria included past history of depression, an EPDS score of nine to 19 (at risk for depression or mildly depressed), singleton gestation, a maternal age of 18 years or older and a gestational age of 12 to 20 weeks.

Exclusion Criteria:

Potential subjects were excluded if they had a history of a bleeding disorder, thrombophilia requiring anti-coagulation, multiple gestation, bipolar disorder, current major depressive disorder, current substance abuse, lifetime substance dependence or schizophrenia. Women were also ineligible if they were currently taking omega-3 fatty acid supplements or anti-depressant medications or eating more than two fish meals per week. For a final determination of eligibility, study staff with training in clinical psychology administered the Mini-International Neuropsychiatric Interview (MINI). The MINI is a structured interview for diagnosis of Diagnostic and Statistical Manual of Mental Disorders-IV and International Classification of Diseases, 10th revision, psychiatric disorders. We used the MINI to exclude current major depressive disorder (MDD), bipolar disorder, current substance abuse or dependence, suicidal ideation or schizophrenia.

Research Purpose:

We carried out this study to directly compare EPA-rich fish oil, DHA-rich fish oil and soy oil placebo for the prevention of depressive symptoms among pregnant women at an increased risk for depression.

Blinding efforts:

The placebos were formulated to be identical in appearance to both the EPA- and DHA-rich supplements and contained 98% soybean oil and 1% each of lemon and fish oil. The supplements were molecularly distilled and free of industrial contaminants, mercury and organochlorines. Because the EPA and DHA capsules were not identical in appearance, we used a double dummy design to maintain blinding. The EPA Group received two large EPA-rich fish oil capsules and four small placebo capsules formulated to appear identical to the DHA-rich fish oil capsules. The DHA Group received two large placebo capsules formulated to appear identical to the EPA-rich fish oil capsules and four small DHA-rich fish oil capsules. The Placebo Group received two large and four small placebo capsules daily.

Study Location:

The University of Michigan Health System and St Joseph’s Mercy Hospital Health System, Ann Arbor, MI

Source(s) of Funding:

Government, Industry, University/Hospital

Please specify names of funders:

NIH (National Center for Complementary and Alternative Medicine), the University of Michigan Clinical Research Initiatives grant, the University of Michigan General Clinical Research Center, NIH through the University of Michigan’s Cancer Center Support Grant, National Center for Research Resources, the National Center for Advancing Translational Sciences, NIH for the Clinical and Translational Science Center, University of New Mexico, The Nordic Naturals Corporation.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	No
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	Yes
5.	Was blinding used to prevent introduction of bias?		???
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	???
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	???
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		No
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	???
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	No
	6.6.	Were extra or unplanned treatments described?	No
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	???
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	???
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	???
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	Yes
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	No
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes