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

NCT06971445

Enrolling By InvitationNA

Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Conditions: Pregnant HIV Positive Women

Interventions: omega-3 polyunsaturated fatty acids (PUFA n-3), Olive oil (placebo)

Countries: Mexico

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Pregnant women
* Single pregnancy
* Gestational age from 20 to 29 weeks since the first day of the last menstrual period
* Agree to participate in the study

Exclusion Criteria:

* Gestational age more than 29 weeks
* With diagnosis of gestational diabetes or preeclampsia
* Smoking and/or drug use during the invitation to participate in the study
* Fish allergy

Locations (1)

Mexico City, Mexico City, Mexico