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ENROLLING BY INVITATION
NCT06971445
NA

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

Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of Polyunsaturated Fatty Acids Omega-3 Supplementation on Pregnancy Outcomes and Inflammation Markers in Pregnant Women HIV+, With Antiretroviral Therapy, Randomized Clinical Trial.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2025-05-14

Completion Date

2029-12

Last Updated

2025-09-11

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

omega-3 polyunsaturated fatty acids (PUFA n-3)

1280 mg of omega-3 polyunsaturated fatty acids (650mg EPA, 450mg DHA, and 179mg ALA) per day for 8 weeks

DIETARY_SUPPLEMENT

Olive oil (placebo)

Softgels containing extra virgin olive oil, with a similar appearance to the experimental group, were given to participants for 8 weeks.

Locations (1)

Instituto Nacional de Perinatologia

Mexico City, Mexico City, Mexico