NCT06971445Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Effect of Polyunsaturated Fatty Acids Omega-3 Supplementation on Pregnancy Outcomes and Inflammation Markers in Pregnant Women HIV+, With Antiretroviral Therapy, Randomized Clinical Trial.
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 6 May 2025
- Start date
- 14 May 2025
- Primary completion date
- Jul 2028
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Diseases
- HIV
- NCT number
- NCT06971445
What you commit to
- Study type: Interventional
- Planned participants: 92
- From 14 May 2025 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Smoking and/or drug use during the invitation to participate in the study
Other illness
- With diagnosis of gestational diabetes or preeclampsia
- Fish allergy
Age
- Gestational age more than 29 weeks
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Perinatologia Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.