DHA Blood Screening for Nutrient Deficiency

(PROmega Trial)

Overseen By Katherine Sauder, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how to integrate testing for DHA, an important nutrient, into early pregnancy care. DHA, a type of omega-3 fatty acid, supports brain and eye development in babies. The trial includes a simple blood test to measure DHA levels in pregnant women. It suits those beginning prenatal care who can undergo early pregnancy blood tests. As an unphased trial, this study provides a unique opportunity for participants to contribute to enhancing prenatal care practices.

What prior data suggests that this DHA blood screening is safe?

Research has shown that testing DHA (docosahexaenoic acid) levels in red blood cells is safe. DHA, an omega-3 fatty acid, plays a crucial role in brain health. Studies indicate that individuals with certain conditions, such as Alzheimer's, may benefit from DHA supplements. This supports the safety of checking DHA levels.

Additionally, taking DHA supplements has proven safe and effective for addressing fatty acid deficiencies in conditions like phenylketonuria. Although this trial focuses on testing rather than supplementation, the safety of DHA-related treatments suggests that testing DHA levels should be well-tolerated.

No evidence suggests any negative effects from the testing process itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DHA Blood Screening because it offers a novel way to identify nutrient deficiencies by measuring DHA levels in the blood. Unlike traditional methods, which may focus on more general blood tests or dietary assessments, this screening specifically targets DHA as a percentage of total fatty acids in red blood cells. This precise measurement can provide a more accurate picture of an individual's omega-3 status, potentially leading to better-tailored nutritional interventions.

What evidence suggests that DHA blood screening is effective for detecting nutrient deficiency?

Research shows that DHA, a type of omega-3 fatty acid, is important for the health of both the mother and the developing baby during pregnancy. Studies have found that DHA supports brain function, heart health, and may even help protect against cancer. DHA can be obtained from eating fish and some plant oils. The amount of DHA in the body usually reflects dietary intake. In this trial, participants will undergo DHA blood screening to measure DHA levels and determine if additional intake through food or supplements is needed. This check can help ensure that pregnant individuals have enough DHA, benefiting both the mother and the baby. ^{3 4 6 7 8}

Who Is on the Research Team?

Katherine Sauder, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This clinical trial is open to pregnant individuals starting prenatal care at participating clinics who are due for early pregnancy blood tests as per ACOG standards. There are no specific exclusion criteria, making it broadly accessible.

Inclusion Criteria

Patients initiating prenatal care at participating clinics who are eligible for early pregnancy blood testing per American College of Obstetricians and Gynecologists (ACOG) standards

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

DHA Blood Screening

Measurement of DHA as percent of total fatty acids in red blood cells

20 weeks

Routine prenatal visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DHA Blood Screening

Trial Overview The study is testing the practicality of routinely checking DHA levels—a crucial nutrient during pregnancy—in the blood of pregnant individuals in their early stages as part of standard clinical care.

How Is the Trial Designed?

Group I: DHA blood screening Experimental Treatment 1 Intervention

Measurement of DHA as percent of total fatty acids in red blood cells

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9824463/

What Is the Evidence for Dietary-Induced DHA Deficiency in ... These data also showed that the proportions of 22:5n-6 declined from 4.31% (ages 26–42 w gestational age), to 3.55% (0–6 m) and to 2.64% (6 m to ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322009620

Omega-3 Fatty Acids EPA and DHA: Health Benefits ... Fish-derived omega-3 fatty acids EPA and DHA have been associated with fetal development, cardiovascular function, and Alzheimer's disease.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ijc.35517

Safety and efficacy of docosahexaenoic acid ... Omega-3 docosahexaenoic acid (DHA) has shown pleiotropic anti-cancer effects both in vitro and in animal models.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06294067

A Dose Response Investigation of Docosahexaenoic Acid ... Provide data for exploratory analysis related to PUFA metabolism, ALA consumption and its effect on EPA and DHA levels, and DHA's effects on disease related ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4772061/

Docosahexaenoic Acid and Cognition throughout the Lifespan This subgroup experienced an eight-month improvement in reading age after DHA supplementation. Moreover, parent-rated behavior problems (ADHD-type symptoms) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8229216/

Beyond Nutrient Deficiency—Opportunities to Improve ... Higher blood EPA + DHA levels appear to protect people exposed to ambient particulate matter air pollutants as they have muted blood fibrinogen responses

7. mdpi.com mdpi.com/2072-6643/15/1/161

What Is the Evidence for Dietary-Induced DHA Deficiency ... The aim of this paper was to explore evidence for the existence of dietary induced reductions in brain DHA levels induced by a dietary n-3 PUFA ...

8. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1676666/full

Docosahexaenoic acid supplementation in phenylketonuria Conclusion: DHA supplementation appears to be a safe and effective strategy to correct LC-PUFA deficiency in PKU, with potential neurophysiological benefits.