Pregnant HIV Positive WomenOM3HIVPROUTINFNCT06971445
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
A study testing omega-3 polyunsaturated fatty acids (PUFA n-3) in people with Pregnant HIV Positive Women, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant HIV Positive Women
- What is being tested?
- omega-3 polyunsaturated fatty acids (PUFA n-3)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteMexico
- Study dates
- 14 May 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Instituto Nacional de Perinatologia
Mexico City, Mexico City, 11000
About this study
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.
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:
- 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?
- 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?
Read more
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.
Read the detailed description
In pregnant women infected with human immunodeficiency virus (HIV), antiretroviral therapy (ART) during pregnancy significantly reduces the risk of neonatal or vertical transmission of the virus. However, these women may face a higher risk of adverse outcomes for their babies, including preterm birth, low birth weight, and being small for their gestational age. HIV infection and ART contribute to a chronic inflammatory state, which has been linked to these negative pregnancy outcomes.
Additionally, the typical diet of pregnant women receiving perinatal care at the Instituto Nacional de Perinatología often lacks sufficient polyunsaturated fats. This is primarily due to limited access to a diverse and high-quality diet, which is frequently influenced by their socioeconomic status. Supplementation with polyunsaturated omega-3 fatty acids (PUFA-n3) during pregnancy has been proposed as a preventive measure against adverse outcomes such as preterm birth and low birth weight. Several studies have documented the efficacy of PUFA-n3 supplementation in this population, particularly among women with a low dietary intake of these fatty acids.
Moreover, even though ART reduces inflammation and immune activation, these levels remain elevated compared to those in healthy individuals, and the imbalance in cytokine profiles persists. ART can also alter cytokine profiles, highlighting the critical need for interventions aimed at reducing chronic inflammation, which can ultimately impact morbidity and mortality in this population.
The relationship between insufficient intake of PUFA-n3 and preterm birth can be attributed to its role in the physiology of delivery. A high ratio of PUFA-n6 to PUFA-n3 may trigger early labor. Therefore, this study aims to evaluate the effects of PUFA-n3 supplementation on birth weight, gestational length, and plasma inflammatory biomarkers in pregnant women using ART.
The sample size for this study was calculated for all the outcome variables. The largest sample size will be used, which was the one calculated to find differences between the means in the IL-6 concentrations of the two supplementation groups, accepting a type I error of 0.05, α=0.05 (1.96), aiming to show a true difference with 0.80 probability, β=0.20 (-0.84). A study in pregnant women was taken as a reference, where the intervention was carried out with a similar dose of PUFA-n3 (1200 mg). The difference found in IL-6 concentrations was 2.8 pg/mL, and following the standard deviation observed in the same study of IL-6 of 4.4 pg/mL. As a result, the sample size will be 38.7 patients per group, plus 20% losses, so 46 patients per group.
The women who meet the inclusion criteria will be invited to participate, and an informed consent letter will be explained and given. Those women who accept will be enrolled in the study. First, they will be randomly assigned to one of the supplementation groups: softgels with 1280mg of PUFA-Ω3 or softgels with a placebo (olive oil).
Allocation to the treatment groups will be done using a table of random numbers, through the software for parallel group clinical trials: Random Allocation Software, created in Microsoft Visual Basic 6 for Windows. Both groups of women will have their usual prenatal care, which includes the Nutrition Care Process. There will be two evaluations, the initial between 20 to 29 weeks of gestational age (GA) according to the first day of the last menstrual period, and the second one, eight weeks after the first (28-37 GA). Both evaluations included: medical history, multiple-pass 24-hour dietary recall, weight measurements, and blood sampling for the inflammatory biomarkers and fatty acid quantification. The pregnancy outcomes, birth weight, and gestational length are going to be obtained from the electronic file. Finally, the statistical analysis will be according to the distribution of outcome variables. The change in the inflammatory biomarkers and the change in the erythrocyte fatty acid profile will be analyzed by a paired t-test or Wilcoxon test. Afterwards, the effect of the supplementation on the pregnancy outcomes and inflammatory biomarkers will be evaluated by the Student t-test or the U-Mann-Whitney test.
- Conditions
- Pregnant HIV Positive Women
- Being tested
- omega-3 polyunsaturated fatty acids (PUFA n-3), Olive oil (placebo)
- Keywords
- Dietary Supplements, Fatty Acids, Omega-3, pregnancy outcomes, HIV Infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 polyunsaturated fatty acids (PUFA n-3)Dietary supplement
1280 mg of omega-3 polyunsaturated fatty acids (650mg EPA, 450mg DHA, and 179mg ALA) per day for 8 weeks
Olive oil (placebo)Dietary supplement
Softgels containing extra virgin olive oil, with a similar appearance to the experimental group, were given to participants for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| omega-3 polyunsaturated fatty acids (PUFA n-3) | Experimental | 1280 mg Polyunsaturated Fatty Acid n3 (650mg EPA, 450mg DHA and179mg ALA) per day for 8 weeks Receives: Dietary Supplement: omega-3 polyunsaturated fatty acids (PUFA n-3) |
| Olive oil | Active comparator | Olive oil softgels with a similar appearance to the experimental softgels (PUFA n-3) for 8 weeks Receives: Dietary Supplement: Olive oil (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weigth
Birth weight (grams) is the first weight of the fetus or newborn obtained within the first hour of life. It will be obtained from the electronic woman's file.
Measured: It will be obtained when the mother's baby is born.
Length of gestation
It will be defined as the time (days) between the first day of the mother's last menstrual period and the day of the baby's born.
Measured: It will be obteined and calculated once the mother's baby is born from de electronic file..
Secondary outcomes (3)
C-reactive protein (CRP)
C-reactive protein (mg/dL), also called CRP, is a protein made by the liver. The level of CRP increases when there's inflammation in the body. It will be quantified in serum and determined by the immunoturbidimetric method using an analyzer, respons®910 Dyasis brand.
Measured: It will be obteined from mothers enrollment (20-28 of gestational age) to the end of suplemmentation at 8 weeks.
Interleukin 6 (IL-6)
IL-6 (pg/mL) is a soluble mediator with a pleiotropic effect on inflammation, immune response, and hematopoiesis. It will be quantified in serum by an ELISA colorimetric assay using a Benchmark plus reader by Bio-Rad.
Measured: It will be obteined from mothers enrollment (20-28 of gestational age) to the end of suplemmentation at 8 weeks.
Prostaglandin E2 (PGE2)
Prostaglandin E2 (PGE2), a principal mediator of inflammation, plays a critical role in cervical ripening. The quantification will be in serum in pg/mL by an ELISA colorimetric assay using a Benchmark plus reader by Bio-Rad..
Measured: It will be obteined from mothers enrollment (20-28 of gestational age) to the end of suplemmentation at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start14 May 2025
- Primary completionJul 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pregnant HIV Positive WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Estela Ytelina Godínez Martínez, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971445
- Sponsor's protocol ID
- 2024-1-40
- Other IDs
- 2024-1-40
- Acronym
- OM3HIVPROUTINF
- Status last verified
- Nov 2026
- First submitted
- 6 May 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD that will be used in the results publication
Publications
Valentine CJ, Khan AQ, Brown AR, Sands SA, Defranco EA, Gajewski BJ, Carlson SE, Reber KM, Rogers LK. Higher-Dose DHA Supplementation Modulates Immune Responses in Pregnancy and Is Associated with Decreased Preterm Birth. Nutrients. 2021 Nov 26;13(12):4248. doi: 10.3390/nu13124248.
PubMed 34959801Best KP, Gomersall J, Makrides M. Prenatal Nutritional Strategies to Reduce the Risk of Preterm Birth. Ann Nutr Metab. 2020;76 Suppl 3:31-39. doi: 10.1159/000509901. Epub 2021 Jan 19.
PubMed 33465767Nikbakht R, Moghadam EK, Nasirkhani Z. Maternal serum levels of C-reactive protein at early pregnancy to predict fetal growth restriction and preterm delivery: A prospective cohort study. Int J Reprod Biomed. 2020 Mar 29;18(3):157-164. doi: 10.18502/ijrm.v18i3.6710. eCollection 2020 Mar.
PubMed 32309764Kalagiri RR, Carder T, Choudhury S, Vora N, Ballard AR, Govande V, Drever N, Beeram MR, Uddin MN. Inflammation in Complicated Pregnancy and Its Outcome. Am J Perinatol. 2016 Dec;33(14):1337-1356. doi: 10.1055/s-0036-1582397. Epub 2016 May 9.
PubMed 27159203Middleton P, Gomersall JC, Gould JF, Shepherd E, Olsen SF, Makrides M. Omega-3 fatty acid addition during pregnancy. Cochrane Database Syst Rev. 2018 Nov 15;11(11):CD003402. doi: 10.1002/14651858.CD003402.pub3.
PubMed 30480773Serra R, Penailillo R, Monteiro LJ, Monckeberg M, Pena M, Moyano L, Brunner C, Vega G, Choolani M, Illanes SE. Supplementation of Omega 3 during Pregnancy and the Risk of Preterm Birth: A Systematic Review and Meta-Analysis. Nutrients. 2021 May 18;13(5):1704. doi: 10.3390/nu13051704.
PubMed 34069867Yeganeh N, Watts DH, Xu J, Kerin T, Joao EC, Pilotto JH, Theron G, Gray G, Santos B, Fonseca R, Kreitchmann R, Pinto J, Mussi-Pinhata MM, Veloso V, Camarca M, Mofenson L, Moye J, Nielsen-Saines K. Infectious Morbidity, Mortality and Nutrition in HIV-exposed, Uninfected, Formula-fed Infants: Results From the HPTN 040/PACTG 1043 Trial. Pediatr Infect Dis J. 2018 Dec;37(12):1271-1278. doi: 10.1097/INF.0000000000002082.
PubMed 29750766Shinar S, Agrawal S, Ryu M, Walmsley S, Serghides L, Yudin MH, Murphy KE. Perinatal outcomes in women living with HIV-1 and receiving antiretroviral therapy-a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2022 Feb;101(2):168-182. doi: 10.1111/aogs.14282. Epub 2021 Oct 27.
PubMed 34704251Eke AC, Mirochnick M, Lockman S. Antiretroviral Therapy and Adverse Pregnancy Outcomes in People Living with HIV. N Engl J Med. 2023 Jan 26;388(4):344-356. doi: 10.1056/NEJMra2212877. No abstract available.
PubMed 36720135
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06971445
- Acronym / sponsor ID
- OM3HIVPROUTINF / 2024-1-40
- Conditions
- Pregnant HIV Positive Women
- Keywords
- Dietary Supplements, Fatty Acids, Omega-3, pregnancy outcomes, HIV Infection
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesOther government
- Study start
- 14 May 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Detailed description
In pregnant women infected with human immunodeficiency virus (HIV), antiretroviral therapy (ART) during pregnancy significantly reduces the risk of neonatal or vertical transmission of the virus. However, these women may face a higher risk of adverse outcomes for their babies, including preterm birth, low birth weight, and being small for their gestational age. HIV infection and ART contribute to a chronic inflammatory state, which has been linked to these negative pregnancy outcomes.
Additionally, the typical diet of pregnant women receiving perinatal care at the Instituto Nacional de Perinatología often lacks sufficient polyunsaturated fats. This is primarily due to limited access to a diverse and high-quality diet, which is frequently influenced by their socioeconomic status. Supplementation with polyunsaturated omega-3 fatty acids (PUFA-n3) during pregnancy has been proposed as a preventive measure against adverse outcomes such as preterm birth and low birth weight. Several studies have documented the efficacy of PUFA-n3 supplementation in this population, particularly among women with a low dietary intake of these fatty acids.
Moreover, even though ART reduces inflammation and immune activation, these levels remain elevated compared to those in healthy individuals, and the imbalance in cytokine profiles persists. ART can also alter cytokine profiles, highlighting the critical need for interventions aimed at reducing chronic inflammation, which can ultimately impact morbidity and mortality in this population.
The relationship between insufficient intake of PUFA-n3 and preterm birth can be attributed to its role in the physiology of delivery. A high ratio of PUFA-n6 to PUFA-n3 may trigger early labor. Therefore, this study aims to evaluate the effects of PUFA-n3 supplementation on birth weight, gestational length, and plasma inflammatory biomarkers in pregnant women using ART.
The sample size for this study was calculated for all the outcome variables. The largest sample size will be used, which was the one calculated to find differences between the means in the IL-6 concentrations of the two supplementation groups, accepting a type I error of 0.05, α=0.05 (1.96), aiming to show a true difference with 0.80 probability, β=0.20 (-0.84). A study in pregnant women was taken as a reference, where the intervention was carried out with a similar dose of PUFA-n3 (1200 mg). The difference found in IL-6 concentrations was 2.8 pg/mL, and following the standard deviation observed in the same study of IL-6 of 4.4 pg/mL. As a result, the sample size will be 38.7 patients per group, plus 20% losses, so 46 patients per group.
The women who meet the inclusion criteria will be invited to participate, and an informed consent letter will be explained and given. Those women who accept will be enrolled in the study. First, they will be randomly assigned to one of the supplementation groups: softgels with 1280mg of PUFA-Ω3 or softgels with a placebo (olive oil).
Allocation to the treatment groups will be done using a table of random numbers, through the software for parallel group clinical trials: Random Allocation Software, created in Microsoft Visual Basic 6 for Windows. Both groups of women will have their usual prenatal care, which includes the Nutrition Care Process. There will be two evaluations, the initial between 20 to 29 weeks of gestational age (GA) according to the first day of the last menstrual period, and the second one, eight weeks after the first (28-37 GA). Both evaluations included: medical history, multiple-pass 24-hour dietary recall, weight measurements, and blood sampling for the inflammatory biomarkers and fatty acid quantification. The pregnancy outcomes, birth weight, and gestational length are going to be obtained from the electronic file. Finally, the statistical analysis will be according to the distribution of outcome variables. The change in the inflammatory biomarkers and the change in the erythrocyte fatty acid profile will be analyzed by a paired t-test or Wilcoxon test. Afterwards, the effect of the supplementation on the pregnancy outcomes and inflammatory biomarkers will be evaluated by the Student t-test or the U-Mann-Whitney test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega-3 polyunsaturated fatty acids (PUFA n-3) | Experimental | Dietary Supplement: omega-3 polyunsaturated fatty acids (PUFA n-3)1280 mg Polyunsaturated Fatty Acid n3 (650mg EPA, 450mg DHA and179mg ALA) per day for 8 weeks |
| Olive oil | Active comparator | Dietary Supplement: Olive oil (placebo)Olive oil softgels with a similar appearance to the experimental softgels (PUFA n-3) for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | omega-3 polyunsaturated fatty acids (PUFA n-3) |
| Olive oil (placebo)Softgels containing extra virgin olive oil, with a similar appearance to the experimental group, were given to participants for 8 weeks. | Dietary supplement | Olive oil |
Primary outcome
Birth weigth
Time frame: It will be obtained when the mother's baby is born.
Birth weight (grams) is the first weight of the fetus or newborn obtained within the first hour of life. It will be obtained from the electronic woman's file.
Length of gestation
Time frame: It will be obteined and calculated once the mother's baby is born from de electronic file..
It will be defined as the time (days) between the first day of the mother's last menstrual period and the day of the baby's born.
3 secondary outcomes
C-reactive protein (CRP)
Time frame: It will be obteined from mothers enrollment (20-28 of gestational age) to the end of suplemmentation at 8 weeks.
Interleukin 6 (IL-6)
Time frame: It will be obteined from mothers enrollment (20-28 of gestational age) to the end of suplemmentation at 8 weeks.
Prostaglandin E2 (PGE2)
Time frame: It will be obteined from mothers enrollment (20-28 of gestational age) to the end of suplemmentation at 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 34959801Valentine CJ, Khan AQ, Brown AR, Sands SA, Defranco EA, Gajewski BJ, Carlson SE, Reber KM, Rogers LK. Higher-Dose DHA Supplementation Modulates Immune Responses in Pregnancy and Is Associated with Decreased Preterm Birth. Nutrients. 2021 Nov 26;13(12):4248. doi: 10.3390/nu13124248.
- Background: PubMed 33465767Best KP, Gomersall J, Makrides M. Prenatal Nutritional Strategies to Reduce the Risk of Preterm Birth. Ann Nutr Metab. 2020;76 Suppl 3:31-39. doi: 10.1159/000509901. Epub 2021 Jan 19.
- Background: PubMed 32309764Nikbakht R, Moghadam EK, Nasirkhani Z. Maternal serum levels of C-reactive protein at early pregnancy to predict fetal growth restriction and preterm delivery: A prospective cohort study. Int J Reprod Biomed. 2020 Mar 29;18(3):157-164. doi: 10.18502/ijrm.v18i3.6710. eCollection 2020 Mar.
- Background: PubMed 27159203Kalagiri RR, Carder T, Choudhury S, Vora N, Ballard AR, Govande V, Drever N, Beeram MR, Uddin MN. Inflammation in Complicated Pregnancy and Its Outcome. Am J Perinatol. 2016 Dec;33(14):1337-1356. doi: 10.1055/s-0036-1582397. Epub 2016 May 9.
- Background: PubMed 30480773Middleton P, Gomersall JC, Gould JF, Shepherd E, Olsen SF, Makrides M. Omega-3 fatty acid addition during pregnancy. Cochrane Database Syst Rev. 2018 Nov 15;11(11):CD003402. doi: 10.1002/14651858.CD003402.pub3.
- Background: PubMed 34069867Serra R, Penailillo R, Monteiro LJ, Monckeberg M, Pena M, Moyano L, Brunner C, Vega G, Choolani M, Illanes SE. Supplementation of Omega 3 during Pregnancy and the Risk of Preterm Birth: A Systematic Review and Meta-Analysis. Nutrients. 2021 May 18;13(5):1704. doi: 10.3390/nu13051704.
- Background: PubMed 29750766Yeganeh N, Watts DH, Xu J, Kerin T, Joao EC, Pilotto JH, Theron G, Gray G, Santos B, Fonseca R, Kreitchmann R, Pinto J, Mussi-Pinhata MM, Veloso V, Camarca M, Mofenson L, Moye J, Nielsen-Saines K. Infectious Morbidity, Mortality and Nutrition in HIV-exposed, Uninfected, Formula-fed Infants: Results From the HPTN 040/PACTG 1043 Trial. Pediatr Infect Dis J. 2018 Dec;37(12):1271-1278. doi: 10.1097/INF.0000000000002082.
- Background: PubMed 34704251Shinar S, Agrawal S, Ryu M, Walmsley S, Serghides L, Yudin MH, Murphy KE. Perinatal outcomes in women living with HIV-1 and receiving antiretroviral therapy-a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2022 Feb;101(2):168-182. doi: 10.1111/aogs.14282. Epub 2021 Oct 27.
- Background: PubMed 36720135Eke AC, Mirochnick M, Lockman S. Antiretroviral Therapy and Adverse Pregnancy Outcomes in People Living with HIV. N Engl J Med. 2023 Jan 26;388(4):344-356. doi: 10.1056/NEJMra2212877. No abstract available.
- Infectious Morbidity, Mortality and Nutrition in HIV-exposed, Uninfected, Formula-fed Infants: Results from the HPTN 040/PACTG 1043 TrialLink provided by the sponsor.
- Inflammation in Complicated Pregnancy and Its OutcomeLink provided by the sponsor.
- Maternal serum levels of C-reactive protein at early pregnancy to predict fetal growth restriction and preterm deliveryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Only IPD that will be used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 polyunsaturated fatty acids (PUFA n-3) in people with Pregnant HIV Positive Women, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth weigth (time frame: It will be obtained when the mother's baby is born.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06971445, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.