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

NCT06971445 | Enrolling By Invitation DMC

• 1 other identifier: 2024-1-40
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Pregnant HIV Positive Women

Keywords

Dietary Supplements; Fatty Acids, Omega-3; pregnancy outcomes; HIV Infection

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  It will be obteined and calculated once the mother's baby is born from de electronic file..

Secondary Outcomes (3)

• C-reactive protein (CRP)

  It will be obteined from mothers enrollment (20-28 of gestational age) to the end of suplemmentation at 8 weeks.

• Interleukin 6 (IL-6)

  It will be obteined from mothers enrollment (20-28 of gestational age) to the end of suplemmentation at 8 weeks.

• Prostaglandin E2 (PGE2)

  It will be obteined from mothers enrollment (20-28 of gestational age) to the end of suplemmentation at 8 weeks.

Other Outcomes (1)

• Erythrocyte Fatty Acid Profile

  It will be obteined from mothers enrollment (20-28 of gestational age) to the end of suplemmentation at 8 weeks.

Study Arms (2)

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

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

Dietary Supplement: Olive oil (placebo)

Interventions

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

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

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.

Olive oil

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes: lead

Study Sites (1)

Instituto Nacional de Perinatologia

Mexico City, Mexico City, 11000, Mexico

Location

Related Publications (9)

• 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.

  PMID: 34959801 BACKGROUND

• Best 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.

  PMID: 33465767 BACKGROUND

• Nikbakht 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.

  PMID: 32309764 BACKGROUND

• Kalagiri 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.

  PMID: 27159203 BACKGROUND

• Middleton 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.

  PMID: 30480773 BACKGROUND

• Serra 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.

  PMID: 34069867 BACKGROUND

• Yeganeh 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.

  PMID: 29750766 BACKGROUND

• Shinar 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.

  PMID: 34704251 BACKGROUND

• Eke 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.

  PMID: 36720135 BACKGROUND

Related Links

• Infectious Morbidity, Mortality and Nutrition in HIV-exposed, Uninfected, Formula-fed Infants: Results from the HPTN 040/PACTG 1043 Trial
• Inflammation in Complicated Pregnancy and Its Outcome
• Maternal serum levels of C-reactive protein at early pregnancy to predict fetal growth restriction and preterm delivery

MeSH Terms

Conditions

HIV Infections

Interventions

Docosahexaenoic Acids; Olive Oil

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in Medical Science B

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the beginning of the study, and until the end of the study
• Access Criteria: Who wanted to know more about this study, and when the results were published, if it is required.

Locations

ME (1)