Trial Outcomes & Findings for Omega-3 Supplementation for Pediatric Migraine (NCT NCT06899074)

Omega-3 Supplementation for Pediatric Migraine

The Omega-3 Index is defined as the combined percentage of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in red blood cell membranes, expressed as a percentage of total fatty acids. Possible range: 0-100%. Higher values indicate greater incorporation of omega-3-fatty acids (favorable outcome). This outcome compares the change in omega-3 index levels via finger prick blood test.

The associations between omega-3 (O3) index levels and pain intensity will be assessed based on validated self-report measures using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Intensity Measure (PPIM). The PROMIS Pain Intensity instruments assess how much the child hurts. The PROMIS Pediatric Pain Intensity Measure is a 3-item, self-report measure for children and adolescents ages 8 to 18 with chronic pain, using a 5-point Likert scale including three items rating pain from "Had no pain" = 1 to "Very severe" = 5. Total raw scores for the short form are summed for the values of the response to each question. Raw score range: 3-15. Raw scores are then converted to t-scores using a standardized scale where 50 represents the average of the general US population, and each 10-point difference represents one standard deviation. T-score range: 26.8-74.1. Higher scores indicate worse or more intense pain.

The associations between omega-3 index levels and pain interference will be assessed based on validated self-report measures using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Scale (PPIS). The PROMIS Pediatric Pain Interference Scale is an 8-item self-report questionnaire completed by children that assesses how pain impacts a child's daily activities of living and the enjoyment of those activities using a 5-point likert scale. This survey is measured on a scale of 1-5, from 1 being never to 5 being almost always. A lower score will indicate less pain interference in the pediatric patient. Raw scores are then converted to t-scores using a standardized scale where 50 represents the average of the general US population, and each 10-point difference represents one standard deviation. T-score range: 43.8-83.5.

The validated Pediatric Migraine Disability Assessment tool (PedMIDAS) was used to measure migraine disability by self-report. PedMIDAS was developed to assess migraine disability in pediatric and adolescent patients ages 4-18. It is intended to be self-administered by the patient and their parent. The PedMIDAS is scored by summing the answers across 6 questions. The raw score ranges from 0 (minimum) to 240 (maximum). Higher scores reflect greater headache-related disability, with clinical cut-off scores graded 0-10 indicating "little to none", 11-30 indicating "mild", 31-50 indicating "moderate", or greater than 50 indicating "severe" migraine disability. The number of participants meeting each category was recorded.

The validated Revised Children's Anxiety and Depression Scale (RCADS)-short version will be used to measure psychological distress by self-report. The RCADS is a 25-item questionnaire designed to assess symptoms of anxiety and depression in children and adolescents aged 8 to 18 years using a 4-point Likert scale. Each item is assigned a numerical value from 0-3, where 0 = Never, 1 = Sometimes, 2 = Often, and 3 = Always, with a raw score range of 0 to 75. Raw scores are converted to standardized T-scores based on their age (grade level) and gender. T-score range: 24-163. RCADS T-scores a reported with a standardized mean of 50 and a standard deviation of 10. A higher T-score indicates a higher level of anxiety and/or depression in the pediatric patient. These standardized scores indicate the severity of their symptoms compared to peers in the general population. T-scores \< 65 indicate normal or low severity; T-scores of 65-69 are borderline; T-scores \>/= 70 are clinical severity.