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Pregnancy ComplicationsPhase 3FACTNCT01355159

High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention

A Phase 3 study testing Folic Acid 4 mg in people with Pregnancy Complications and Preeclampsia, run by Ottawa Hospital Research Institute at 72 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To determine the efficacy of high dose folic acid supplementation for prevention of preeclampsia in women with at least one risk factor: pre-existing hypertension, pre-pregnancy diabetes (type 1 or 2), twin pregnancy, preeclampsia in a previous pregnancy, or body mass index ≥35. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy Complications, Preeclampsia
What is being tested?
Folic Acid 4 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,464 participants
Where
72 sitesin 5 countries
Study dates
Apr 2011to Sep 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Capability of subject to comprehend and comply with study requirements
  • ≥ 18 years of age at time of consent
  • Subject is taking ≤1.1 mg of folic acid daily at the time of randomization
  • Live fetus (documented positive fetal heart prior to randomization)
  • Gestational age between 8+0 and 16+6 weeks of pregnancy (Gestational age (GA) of subjects will be calculated based on the first day of the last menstrual period (LMP) or ultrasound performed before 12+6. If early ultrasound and LMP dates differ by ≤ 7 days, base GA estimate on LMP date; if > 7 days, use early < 12+6 ultrasound)
  • Subject plans to give birth in a participating hospital site
Show all 12Show fewer
  • Pregnant subjects must fulfill at least one of the following identified risk factors for pre-eclampsia (PE):
  • Pre-existing hypertension (documented evidence of diastolic blood pressure ≥ 90 mmHg on two separate occasions or at least 4 hours apart prior to randomization, or use of antihypertensive medication during this pregnancy specifically for the treatment of hypertension prior to randomization)
  • Pre-pregnancy diabetes (documented evidence of Type I or type II DM)
  • Twin pregnancy
  • Documented evidence of history of PE in a previous pregnancy
  • BMI > 35 kg/m2 within 3 months prior to this pregnancy and up to randomization of this pregnancy (documented evidence of height and weight to calculate BMI is required)

Who cannot join

  • Known history or presence of any clinically significant disease or condition which would be a contraindication to folic acid supplementation of up to 5 mg daily for the duration of pregnancy
  • Known major fetal anomaly or fetal demise
  • History of medical complications, including:
  • renal disease with altered renal function,
  • epilepsy,
  • cancer, or
Show all 14Show fewer
  • use of folic acid antagonists such as valproic acid
  • Individual who is currently enrolled or has participated in another clinical trial or who received an investigational drug within 3 months of the date of randomization (unless approved by the Trial Coordinating Centre)
  • Known presence of:
  • Alcohol abuse (≥ 2 drinks per day) or alcohol dependence
  • Illicit drug/substance use and/or dependence
  • Known hypersensitivity to folic acid
  • Multiple Pregnancy (triplets or more)
  • Participation in this study in a previous pregnancy

Trial locations and contacts

72 sites in 5 countries.

72 sites in 5 countries

United Kingdom32 sites

  • Wansbeck General Hospital

    Ashington, Northumberland, NE63 9JJ

  • Blackburn

    Blackburn, BB2 3HH

  • Burnley

    Burnley, BB10 2PQ

  • Fairfield

    Bury, Lancashire, BL9 7TD

  • Cumberland Infirmary

    Carlisle, Cumbria, CA27HY

  • North Manchester

    Crumpsall, M8 5RB

  • Darlington Memorial Hospital

    Darlington, County Durham, DL3 6HX

  • University Hospital of North Durham

    Durham, County Durham, DH1 5TW

  • Gateshead Queen Elizabeth Hospital

    Gateshead, Tyne and Wear, NE9 6SX

  • Northwick Park Hospital

    Harrow, Middlesex, HA1 3UJ

  • Hinchingbrooke

    Huntingdon, Cambridgeshire, PE29 6NT

  • West Middlesex University Hospital

    Isleworth, Middlesex, TW7 6AF

  • Lincolnshire

    Lincoln, Lincolnshire, LN2 4AX

  • St George's Hospital

    London, Tooting, SW17 0QT

  • Guy's & St Thomas' Hospital

    London, SE1 9RT

  • South Tees Hospital

    Middlesbrough, TS4 3BW

  • Newcastle upon Tyne Hospitals

    Newcastle upon Tyne, NE1 4LP

  • North Tyneside General Hospital

    North Shields, NE29 8NH

  • Norfolk & Norwich

    Norwich, NR4 7UY

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Nottingham Queens Medical Centre

    Nottingham, NG7 2UH

  • Oldham

    Oldham, OL1 2JH

  • Rochdale

    Rochdale, Lancashire, OL12 0NB

  • South Tyneside District Hospital

    South Shields, Tyne and Wear, NE34 0PL

  • Ormskirk

    Southport, Merseyside, PR8 6PN

  • North Tees Hospital

    Stockton, TS19 9AH

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP

  • Hillingdon Hospital

    Uxbridge, UB8 3NN

  • Warrington and Halton Hospitals NHS Foundation Trust

    Warrington, Cheshire, WA51QC

  • West Cumberland Hospital

    Whitehaven, Cumbria, CA288JG

  • 49 Marine Avenue & CCGs

    Whitley Bay, Newcastle Upon Tyne, NE13 9BA

  • The Royal Wolverhampton NHS Trust, New Cross Hospital

    Wolverhampton, West Midlands, WV100QP

Other trials in United Kingdom

Canada23 sites

  • Calgary Foothills Medical Center

    Calgary, Alberta, T2N2T9

  • Edmonton Lois Hole Hospital for Women

    Edmonton, Alberta, T5H 3V9

  • Fredericton Dr. Everett Chalmers Regional Hospital

    Fredericton, New Brunswick, E3B 5N5

  • Hamilton McMaster University

    Hamilton, Ontario, L8S 4K1

  • Kingston

    Kingston, Ontario, K7L 2V7

  • London

    London, Ontario, N6A 5W9

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Quebec City (CHUL) Centre Hospitalier Universitaire

    Montreal, Quebec, G1V 4G2

  • Saint-Luc CHUM - Montreal

    Montreal, Quebec, H2X 3J4

  • McGill University Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • St-Mary's Hospital

    Montreal, Quebec, H3T 1M5

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Civic Hospital

    Ottawa, Ontario, K1Y 4E9

  • Regina Qu'Appelle Health Region

    Regina, Saskatchewan, S4P 0W5

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Sault Ste- Marie Sault Area Hospital

    Sault Ste. Marie, Ontario, P6B 0A8

  • St-John's Women's Health Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Sunnybrook Health Sciences

    Toronto, Ontario, M4N 3M5

  • Vancouver BC Women's Hospital and Health Center

    Vancouver, British Columbia, V5Z 4H4

  • St-Paul's Hospital

    Vancouver, British Columbia, V6Z 2K5

  • Winnipeg St. Boniface General Hospital

    Winnipeg, New Brunswick, R2H 2A6

  • Winnipeg University of Manitoba

    Winnipeg, New Brunswick, R3E 3P4

Other trials in Canada

Argentina8 sites

  • Cemic

    Buenos Aires

  • Hospital Escuela Eva Perón

    Rosario, Santa Fe Province, S2000DKR

  • Hospital Provincial

    Rosario, Santa Fe Province

  • Hospital Roque Saenz Penia

    Rosario, Santa Fe Province

  • Maternidad Martin

    Rosario, Santa Fe Province

  • Sanatorio de la Mujer

    Rosario, Santa Fe Province

  • Hospital Cullen

    Santa Fe

  • Hosptial Iturraspe

    Santa Fe

Other trials in Argentina

Australia6 sites

  • Townsville

    Douglas, Queensland, 4814

  • Ipswich

    Ipswich, Queensland, 4305

  • Adelaide

    North Adelaide, South Australia, 5006

  • Royal Women's Hospital

    Parkville, Victoria, 3052

  • Nepean

    Penrith, New South Wales, 2750

  • Sunshine

    St Albans, Victoria, 3021

Other trials in Australia

Jamaica3 sites

  • Jubilee

    Kingston

  • Spanishtown

    Kingston

  • University of West Indies

    Kingston

Other trials in Jamaica

About this study

Official title: Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia-Folic Acid Clinical Trial (FACT)

To determine the efficacy of high dose folic acid supplementation for prevention of preeclampsia in women with at least one risk factor: pre-existing hypertension, pre-pregnancy diabetes (type 1 or 2), twin pregnancy, preeclampsia in a previous pregnancy, or body mass index ≥35. It was hypothesized that high dose (4.0 mg per day) supplementation starting in early pregnancy and continued throughout the entire pregnancy will lower the incidence of preeclampsia in pregnant women at high risk of developing preeclampsia.

Read the detailed description

Preeclampsia is a complication of pregnancy which affects at least 5% of all pregnancies worldwide and has serious health consequences to these women and their babies. Preeclampsia is hypertension (high blood pressure) in pregnancy with proteinuria. Proteinuria is when protein is found in the urine, and it is a sign that the kidneys are not functioning properly. The only effective treatment for preeclampsia is delivery of the baby. Because delivery may be required before the anticipated date of delivery; preeclampsia is also one of the leading causes of preterm delivery and accounts for 25% of very low birth weight infants. Recent research has also shown that women who have had preeclampsia during pregnancy are more likely to be at risk for future cardiovascular events later in life.

Recently some studies have shown that supplementation with multivitamins containing folic acid is associated with a reduced risk of developing preeclampsia. These findings also suggested that for the prevention of preeclampsia, a high dose of folic acid (much higher than the amount of folate received from food intake or what is usually taken during pregnancy) may be needed.

A randomized controlled trial was conducted in 70 obstetrical centres in 5 countries (Argentina, Australia, Canada, Jamaica, and the UK) to evaluate the effect of high dose folic acid started in early pregnancy on the risk of developing preeclampsia in high-risk women. A sample size of 2464 allowed for 80% power and a 10% loss to follow-up/study withdrawal. Participants received either placebo or four 1.0 mg oral tablets of folic acid.

Being tested
Folic Acid 4 mg, Placebo
Keywords
Pregnancy, Folic Acid supplementation, Preeclampsia
Medical subject headings
Pregnancy Complications, Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Folic Acid 4 mgDrug

    Also called Folate

    Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid

  • PlaceboDrug

    Placebo x 4 tablets will be taken daily by oral administration.

Study groups in NCT01355159
Study groupRoleWhat they receive
Folic Acid 4 mgExperimentalFolic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid
Receives: Drug: Folic Acid 4 mg
PlaceboPlacebo comparatorWomen will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preeclampsia

    PE is defined as diastolic blood pressure ≥90 mmHg on two occasions ≥4 hours apart and proteinuria developed in women greater than 20+0 weeks of gestation. Proteinuria is defined as: urinary protein ≥300mg in 24 hour urine collection OR in the absence of 24 hour collection, ≥2+ dipstick proteinuria, OR random protein-creatinine ratio ≥30mg protein/mmol.

    OR HELLP (Haemolysis, Elevated, Liver Enzymes, Low Platelets) syndrome defined as: Haemolysis (characteristic peripheral blood smear), Serum LDH ≥ 600U/L, Serum AST ≥ 70U/L, and Platelet count <100 x109/L

    OR Superimposed pre-eclampsia, defined as history of pre-existing hypertension (diagnosed pre-pregnancy or before 20+0 weeks' gestation) with new proteinuria.

    Measured: Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery)

Secondary outcomes (24)

  1. Maternal Death

    According to the World Health Organization, "A maternal death is defined as the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes.

    Measured: Time Frame: Participants will be followed from 20+0 weeks of gestation until 42 days postpartum (after delivery)

  2. Spontaneous Abortion

    Spontaneous abortion or miscarriage defined as death of a fetus <500g or <20 weeks of gestation

    Measured: Participants will be followed from randomization until 20+0 weeks of gestation

  3. Placenta Abruption

    Placental abruption (abruptio placentae) is the premature detachment of a normally positioned placenta from the wall of the uterus.

    Measured: Participants will be followed from 20+0 weeks of gestation until delivery

  4. Premature Rupture of Membranes

    Rupture of the membranes (rupture of the amniotic sac) before the onset of labor.

    Measured: Participants will be followed from randomization (8-16 weeks' completed gestation) until the onset of labor

  5. Preterm Birth

    Birth that occur earlier than 37+0 weeks of gestational age.

    Measured: Participants will be followed from 20+0 weeks to 36+6 weeks of gestation

  6. HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count)

    Haemolysis (characteristic peripheral blood smear), Serum LDH >=600U/L, Serum AST >=70U/L, Platelet count <100 x109/L

    Measured: Participants will be followed from 20+0 weeks of gestation until delivery

  7. Severe Preeclampsia

    Severe PE: Defined as PE with convulsion or HELLP or delivery <34 weeks.

    Measured: Participants will be followed from 20+0 weeks of gestation until delivery.

  8. Antenatal Inpatient Length of Stay

    Length of inpatient stay before admission for delivery in days

    Measured: Participants will be followed from date of randomization (8-16 weeks' completed gestation) until admission for delivery

  9. Stillbirth

    Fetal death defined as death of fetus of at least 500 grams birth weight or, if birth weight is unavailable, a gestational age of at least 20+0 weeks of gestation.

    Measured: Participants will be followed from 20+0 weeks of gestation up to delivery.

  10. Intrauterine Growth Restriction (<3rd Percentile)

    Intrauterine growth restriction is defined as a birth weight less than the 3rd percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard.

    Measured: Participants will be followed from 20+0 weeks of gestation until delivery

  11. Intrauterine Growth Restriction (<10th Percentile)

    Intrauterine growth restriction is defined as a birth weight less than the 10th percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard.

    Measured: Participants will be followed from 20+0 weeks of gestation until delivery

  12. Neonatal Death

    Neonatal death defined as death of a baby that occurred during first 28 days of life.

    Measured: Participants will be followed from birth until 28 days of life

  13. Perinatal Mortality

    The perinatal mortality is defined as the number of deaths (fetal deaths and neonatal deaths) of babies ≥ 500 grams birth weight or, if birth weight is unavailable, a gestational age ≥ 20+0 weeks, up to 28 completed days after birth.

    Measured: Participants will be followed from 20+0 weeks of gestation until 28 days of life.

  14. Retinopathy of Prematurity

    Retinopathy of prematurity a retinopathy typically occurring in premature infants treated with high concentrations of oxygen, characterized by vascular dilatation, proliferation, tortuosity, edema, retinal detachment, and fibrous tissue behind the lens confirmed by retinal examination according to an International Committee for the Classification of Retinopathy of Prematurity.

    Measured: Infants born to the participant will be followed for the duration of hospital stay, or up to 6 weeks

  15. Early Onset Sepsis

    Within first 48hr of life, confirmed by positive blood or cerebrospinal fluid cultures

    Measured: Infants born to the participants will be followed first 48 hours of life.

  16. Necrotising Enterocolitis

    Necrotizing enterocolitis (NEC) according to modified Bell's criteria stage 2 or higher (grossly bloody stool, plus absent bowel sounds with or without abdominal tenderness and radiographic findings such as intestinal dilation, ileus, pneumatosis intestinalis), excluding isolated spontaneous intestinal perforations.

    Measured: Infants borm to the participants will be followed for the duration of hospital stay, or up to 6 weeks.

  17. Intraventricular Hemorrhage (IVH)

    • IVH Grade 1(Blood in germinal matrix)
    • IVH Grade 2 (Blood in germinal matrix and extending into the ventricles)
    • IVH Grade 3 (Ventricular enlargement)
    • IVH Grade 4 (Intraparenchymal lesion)

    Measured: Time Frame: Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks

  18. Ventilation

    Ventilatory support after initial resuscitation, with/without intubation.

    Measured: Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks.

  19. Need for Oxygen at 28 Days

    Measured: Infants to the participants will be followed for 28 days after birth.

  20. Composite Severe Adverse Fetal/Neonatal Outcome

    Composite outcome included any of retinopathy of prematurity, periventricular leukomacia, early onset sepsis, necrotizing enterocolitis, intraventricular haemorrhage, ventilation. Need for O2at 28 days, NICU admission

    Measured: Outcomes included in the composite outcome were measured for each of their respective time frames, up to 6-weeks after birth

  21. Length of Stay in 'High Level' Neonatal Care Unit

    Measured: Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.

  22. Neonatal Death

    Neonatal death defined as death of the infant occurred before 28 days of life

    Measured: Infants to the participants will be followed for 28 days after birth.

  23. Periventricular Leukomalacia

    One of the two outcomes used to measure neonatal morbidity.

    Measured: Infants to the participants were followed for 28 days after birth.

  24. Neonatal Intensive Care Unit (NICU) Admission

    This outcome measured whether or not the infant was admitted into the NICU.

    Measured: Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJul 2016
  4. Study completionSep 2016

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,464 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01355159
Sponsor's protocol ID
2009-107
Other IDs
ISRCTN23781770
Acronym
FACT
Status last verified
Jun 2020
First submitted
11 May 2011
Last updated
7 Jul 2020
Data monitoring committee
Yes

Publications

  • Muldoon KA, McLean C, El-Chaar D, Corsi DJ, Rybak N, Dagvadorj A, Guo Y, Rennicks White R, Dingwall-Harvey ALJ, Gaudet LM, Walker MC, Wen SW; FACT Collaborating Group. Persisting risk factors for preeclampsia among high-risk pregnancies already using prophylactic aspirin: a multi-country retrospective investigation. J Matern Fetal Neonatal Med. 2023 Dec;36(1):2200879. doi: 10.1080/14767058.2023.2200879.

    PubMed 37073421

  • Rose EG, Murphy MSQ, Erwin E, Muldoon KA, Harvey ALJ, Rennicks White R, MacFarlane AJ, Wen SW, Walker MC. Gestational Folate and Folic Acid Intake among Women in Canada at Higher Risk of Pre-Eclampsia. J Nutr. 2021 Jul 1;151(7):1976-1982. doi: 10.1093/jn/nxab063.

    PubMed 33851221

  • Corsi DJ, Gaudet LM, El-Chaar D, White RR, Rybak N, Harvey A, Muldoon K, Wen SW, Walker M. Effect of high-dose folic acid supplementation on the prevention of preeclampsia in twin pregnancy. J Matern Fetal Neonatal Med. 2022 Feb;35(3):503-508. doi: 10.1080/14767058.2020.1725882. Epub 2020 Feb 18.

    PubMed 32067533

  • Wen SW, White RR, Rybak N, Gaudet LM, Robson S, Hague W, Simms-Stewart D, Carroli G, Smith G, Fraser WD, Wells G, Davidge ST, Kingdom J, Coyle D, Fergusson D, Corsi DJ, Champagne J, Sabri E, Ramsay T, Mol BWJ, Oudijk MA, Walker MC; FACT Collaborating Group. Effect of high dose folic acid supplementation in pregnancy on pre-eclampsia (FACT): double blind, phase III, randomised controlled, international, multicentre trial. BMJ. 2018 Sep 12;362:k3478. doi: 10.1136/bmj.k3478.

    PubMed 30209050

  • Wen SW, Champagne J, Rennicks White R, Coyle D, Fraser W, Smith G, Fergusson D, Walker MC. Effect of folic acid supplementation in pregnancy on preeclampsia: the folic acid clinical trial study. J Pregnancy. 2013;2013:294312. doi: 10.1155/2013/294312. Epub 2013 Nov 18.

    PubMed 24349782

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Folic Acid 4 mg in people with Pregnancy Complications and Preeclampsia, run by Ottawa Hospital Research Institute at 72 sites in 5 countries.

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 12 inclusion and 14 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: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United Kingdom, Canada, Argentina, Australia, Jamaica. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Preeclampsia (time frame: Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery)). 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 NCT01355159, which also lists 5 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 7 Jul 2020.

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