Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy

This clinical trial aims to determine the effect of PUFA-n3 supplementation on birth weight, gestational length, and plasma inflammatory markers in pregnant women with HIV who are on antiretroviral therapy. The key questions this study seeks to answer are: 1. Will the neonates of HIV-positive women who received 1280 mg of PUFA-n3 supplementation during pregnancy have higher birth weights and longer gestation periods compared to the neonates of HIV-positive women who received a placebo? 2. Will the inflammatory markers in HIV-positive women who received 1280 mg of PUFA-n3 during pregnancy differ from those of HIV-positive women who received a placebo? Researchers will compare the effects of 1280 mg of PUFA-n3 supplementation against a placebo (olive oil) to determine if the supplement can increase birth weight, gestational length, and attenuate the inflammation. Participants in the study will: * Take a prenatal multivitamin that includes 300 mg of PUFA-n3 * Take either 1280 mg of PUFA-n3 or a placebo daily for 8 weeks, starting from a gestational age of 20-29 weeks. * Visit the hospital at the beginning of the study and again 8 weeks later for blood sampling. Additionally, they will have follow-up visits every 2 weeks to monitor gestational weight gain and dietary intake. * Keep a diary to register their supplement intake and record any side effects.

NCT Number	NCT06971445
Lead Sponsor	Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Conditions	Pregnant HIV Positive Women
Enrollment	92 participants
Start Date	2025-05-14
Primary Completion	2028-07 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2025-09-11