Grant Abstract: Long-term Effects and Safety of DHA Supplementation in Toddlerhood for Children born Preterm - Administrative Supplement
Grant Number: 3R01HD100493-04S1
PI Name: Keim
Project Title: Long-term Effects and Safety of DHA Supplementation in Toddlerhood for Children born Preterm - Administrative Supplement
Abstract: Omega-3 docosahexaenoic fatty acid (DHA) supplementation is popular among families with young children due to its perceived benefits for neurodevelopment. However, clinical trials on this are limited, particularly among children born preterm (1 in 10 children in the U.S.) who are at increased risk of cognitive deficits. Our ongoing current grant, 5R01HD100493, examines the effects of 180-day DHA plus arachidonic acid supplementation at age 1 year on cognitive outcomes at age 9-10 among former preterm infants. Pediatric psychiatric disorders are rising in the US, and children born preterm are at increased risk of these outcomes. It is plausible that symptoms of depression and anxiety may moderate the supplements potential benefits on cognitive outcomes as such disorders have previously been associated with poorer executive function, but this remains unexplored. Further, some trials have found evidence of omega-3 supplementation benefits in mood and anxiety disorders. However, these trials were short and designed to treat symptoms of diagnosed disorders rather than prevent them. There is a critical need to understand whether depression and anxiety symptoms are moderators of the supplementation’s potentially beneficial effects on cognitive outcomes at age 9-10 and to determine examine if DHA supplementation in early life can have long-term preventive effects on depression and anxiety symptoms in childhood. The objective of this proposed Administrative Supplement, submitted in response to ODS PA-20-277, is to determine whether depression and anxiety-like symptoms are a moderator (effect modifier) of the effect of DHA supplementation at age 1 on general cognitive ability, language and executive function at age 9-10, and to assess if supplementation prevents the development of depression and anxiety symptoms and diagnoses to age 9-10. The rationale is that it will offer identification of subgroups of children that may/may not benefit from early DHA supplementation, and will clarify if supplementation can prevent mental health outcomes by pursuing 2 aims: 1) Evaluate depression and anxiety related symptoms and diagnoses in mid-childhood as potential moderators (effect modifiers) of the long-term effect of DHA supplementation (vs placebo) at age 1 on general cognitive ability, language and executive function at age 9-10; 2) Evaluate the effect of DHA supplementation (compared to placebo) at age 1 on the longitudinal emergence of depression and anxiety related symptoms and diagnoses from early childhood to age 9-10. The approach is an examination of the long-term cognitive and mental health outcomes of children from a randomized controlled trial of DHA supplementation in toddlerhood, and is innovative in its use of multi- informant reports as well as data from a variety of clinical settings. The contribution is significant in that its focus on moderators will facilitate treatment matching/tailoring for cognitive outcomes, and potentially provide evidence for a low-cost low-burden preventive intervention for pediatric mental health outcomes. PUBLIC HEALTH RELEVANCE: The proposed research is relevant to public health because the results are expected to have an important positive impact¸ by identifying subgroups of children who may benefit more from an early life omega 3 supplementation in terms of cognitive outcomes, and by evaluating a potentially preventive dietary supplement tool for pediatric mental health. The project is relevant to the mission of the Office of Dietary Supplements because it is expected to strengthen knowledge and understanding of dietary supplements by advancing knowledge on omega-3 supplementation in a special population group (children born preterm) and integrating an understudied health outcome of urgent public health importance (pediatric mental health) with a preventive lens.
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