A Phase 2 Randomized Double-blind, Placebo-controlled Clinical Trial of Intravenous Citrulline for Vaso-occlusive Pain Episode in Hospitalized Patients with Sickle Cell Disease (CONQUER SCD Pain Trial)

The goal of this clinical trial is to learn if intravenous citrulline works to treat acute pain in hospitalized patients with sickle cell disease. It will also learn about the safety of intravenous citrulline. The main questions it aims to answer are:
* Does intravenous citrulline decrease the duration of sickle cell pain during hospitalization
* What medical problems do participants have when taking intravenous citrulline? Researchers will compare intravenous citrulline to a placebo (a look-alike substance that contains no drug) to see if intravenous citrulline works to treat acute pain.
Participants will:
* Receive baseline tests and intravenous citrulline for 16 hours during the hospital stay
* After hospital discharge, visit the clinic in about 30 days for checkup and tests

Start Date01 Nov 2024

Sponsor / Collaborator

Children's National Research Institute

[+1]

NL-OMON56806 / SuspendedNot ApplicableIIT

Boosting the bone biology. The effect of oral L-citrulline supplementation on mesenchymal stem cell concentration and osteogenic potential of BMAC in healthy humans. A randomized open-label pilot study. - Boosting the bone biology

Start Date01 Feb 2024

Sponsor / Collaborator-

NCT06212765 / Not yet recruitingPhase 3IIT

Effects of Oral Citrulline Supplementation on Fat-free Mass in COPD Patients With Malnutrition

Chronic obstructive pulmonary disease (COPD) is complicated by malnutrition in 20-70% of cases. In COPD, low fat-free mass is associated with a higher risk of morbidity and mortality. L-citrulline is a non-protein amino acid that has a direct effect on muscle protein synthesis. Oral supplementation with L-citrulline (10 g/day) in malnourished patients has shown to increase fat-free mass. The effects of L-citrulline supplementation in malnourished COPD patients are unknown.
The main objective of this prospective, single-centre, randomised, double-blind, placebo-controlled study will be to determine the impact of 45 days of nutritional supplementation with L-citrulline (10 g/day) on lean body mass (fat-free mass index (in kg.m-2) measured by bioelectrical impedance analysis) in malnourished patients (BMI < 20 kg/m2 if < 70 years old or < 22 kg/m2 if ≥ 70 years old) with COPD at stages 3-4 of the GOLD classification.

Start Date25 Jan 2024

Sponsor / Collaborator

Centre Hospitalier Universitaire de Grenoble

100 Clinical Results associated with L-Citrulline

100 Translational Medicine associated with L-Citrulline

100 Patents (Medical) associated with L-Citrulline

366

Literatures (Medical) associated with L-Citrulline

01 May 2024·Journal of Perinatology

Enteral L-citrulline supplementation in preterm infants is safe and effective in increasing plasma arginine and citrulline levels—a pilot randomized trial

Article

Author: Jain, Sunil K ; Bhatia, Snigdha ; Mehdi, Mohammad Q ; Franco-Fuenmayor, Maria E ; Qasim, Amna

OBJECTIVEDeficiencies of citrulline and arginine have been associated with adverse outcomes in preterm-infants and data regarding enteral supplementation in preterm infants is limited.STUDY DESIGNThis randomized -trial [NCT03649932] included 42 preterm infants (gestational age ≤33 weeks) randomized to receive enteral L-citrulline in low (100 mg/kg/day), medium (200 mg/kg/day) and high-dose (300 mg/kg/day) groups for 7 days. Plasma citrulline and arginine levels were obtained pre-and-post supplementation and efficacy was determined by a significant increase in levels after supplementation. A p < 0.05 was considered significant. Safety monitoring included blood-pressure-monitoring as well as complications and death during hospitalization.RESULTSA total of 40/42 (95%) of the recruits completed the 7-day supplementation with no adverse events. Plasma-citrulline levels increased significantly in all three groups while plasma-arginine levels increased significantly in the high-dose group.CONCLUSIONEnteral L-citrulline supplementation in preterm infants is safe and effective in increasing plasma citrulline and arginine levels.CLINICAL TRIAL REGISTRATIONNCT03649932 https://clinicaltrials.gov/ct2/show/NCT03649932 .

01 Mar 2024·Journal of Inherited Metabolic Disease

Impact of citrulline substitution on clinical outcome after liver transplantation in carbamoyl phosphate synthetase 1 and ornithine transcarbamylase deficiency

Article

Author: Landau, Yuval E ; Ellaway, Carolyn ; Vockley, Jerard ; Zöggeler, Thomas ; Stepien, Karolina M ; Oberhuber, Rupert ; McKiernan, Patrick ; Scholl-Bürgi, Sabine ; Vogel, Georg F ; Schneeberger, Stefan ; Kwok, Anne Mei-Kwun ; Kelifova, Silvie ; Lund, Allan M ; Mori, Mari ; Yıldız, Yılmaz ; Honzik, Tomas ; El-Gharbawy, Areeg H ; Grünert, Sarah C ; Waldner, Birgit ; Müller, Thomas ; Karall, Daniela ; Aldrian, Denise ; Al Mutairi, Fuad

AbstractCarbamoyl phosphate synthetase 1 (CPS1) and ornithine transcarbamylase (OTC) deficiencies are rare urea cycle disorders, which can lead to life‐threatening hyperammonemia. Liver transplantation (LT) provides a cure and offers an alternative to medical treatment and life‐long dietary restrictions with permanent impending risk of hyperammonemia. Nevertheless, in most patients, metabolic aberrations persist after LT, especially low plasma citrulline levels, with questionable clinical impact. So far, little is known about these alterations and there is no consensus, whether l‐citrulline substitution after LT improves patients' symptoms and outcomes. In this multicentre, retrospective, observational study of 24 patients who underwent LT for CPS1 (n = 11) or OTC (n = 13) deficiency, 25% did not receive l‐citrulline or arginine substitution. Correlation analysis revealed no correlation between substitution dosage and citrulline levels (CPS1, p = 0.8 and OTC, p = 1). Arginine levels after liver transplantation were normal after LT independent of citrulline substitution. Native liver survival had no impact on mental impairment (p = 0.67). Regression analysis showed no correlation between l‐citrulline substitution and failure to thrive (p = 0.611) or neurological outcome (p = 0.701). Peak ammonia had a significant effect on mental impairment (p = 0.017). Peak plasma ammonia levels correlate with mental impairment after LT in CPS1 and OTC deficiency. Growth and intellectual impairment after LT are not significantly associated with l‐citrulline substitution.

01 Mar 2024·Molecular Genetics and Metabolism

Impact of supplementation with L-citrulline/arginine after liver transplantation in individuals with Urea Cycle Disorders

Article

Author: Ramdhouni, Nesrine ; Gallagher, Renata C. ; Baumgartner, Matthias R. ; Le Mons, Cynthia ; Nagamani, Sandesh C.S. ; Konczal, Laura ; Lindner, Martin ; Druck, Ann-Catrin ; Ficicioglu, Can ; Wong, Derek ; Lam, Christina ; Berry, Gerard T. ; Gleich, Florian ; Dobbelaere, Dries ; Burrage, Lindsay C. ; Posset, Roland ; Gropman, Andrea L. ; McCandless, Shawn E. ; Schulze, Andreas ; Harding, Cary O. ; Seminara, Jennifer ; Zielonka, Matthias ; Stricker, Tamar ; Breilyn, Margo ; Mew, Nicholas Ah. ; Wilkening, Greta ; Diaz, George A. ; Kölker, Stefan ; Enns, Gregory M. ; Lawrence Merritt, J. ; Hoffmann, Georg F. ; García-Cazorla, Angeles ; Epp, Friederike ; Garbade, Sven F. ; Coughlin, Curtis R. ; Berry, Susan A.

OBJECTIVELiver transplantation (LTx) is an intervention when medical management is not sufficiently preventing individuals with urea cycle disorders (UCDs) from the occurrence of hyperammonemic events. Supplementation with L-citrulline/arginine is regularly performed prior to LTx to support ureagenesis and is often continued after the intervention. However, systematic studies assessing the impact of long-term L-citrulline/arginine supplementation in individuals who have undergone LTx is lacking to date.METHODSUsing longitudinal data collected systematically, a comparative analysis was carried out by studying the effects of long-term L-citrulline/arginine supplementation vs. no supplementation on health-related outcome parameters (i.e., anthropometric, neurological, and cognitive outcomes) in individuals with UCDs who have undergone LTx. Altogether, 52 individuals with male ornithine transcarbamylase deficiency, citrullinemia type 1 and argininosuccinic aciduria and a pre-transplant "severe" disease course who have undergone LTx were investigated by using recently established and validated genotype-specific in vitro enzyme activities.RESULTSLong-term supplementation of individuals with L-citrulline/arginine who have undergone LTx (n = 16) does neither appear to alter anthropometric nor neurocognitive endpoints when compared to their severity-adjusted counterparts that were not supplemented (n = 36) after LTx with mean observation periods between four to five years. Moreover, supplementation with L-citrulline/arginine was not associated with an increase of disease-specific plasma arithmetic mean values for the respective amino acids when compared to the non-supplemented control cohort.CONCLUSIONAlthough supplementation with L-citrulline/arginine is often continued after LTx, this pilot study does neither identify altered long-term anthropometric or neurocognitive health-related outcomes nor does it find an adequate biochemical response as reflected by the unaltered plasma arithmetic mean values for L-citrulline or L-arginine. Further prospective analyses in larger samples and even longer observation periods will provide more insight into the usefulness of long-term supplementation with L-citrulline/arginine for individuals with UCDs who have undergone LTx.

News (Medical) associated with L-Citrulline

05 Oct 2023

·www.prnewswire.com

Bizz Energy Is a Clean, Mean Way to Beat the Modern Midday Slump

The Energy Drink Formula Unleashes Unique Levels of Energy Whilst Avoiding Sugar Crashes and Unhealthy Ingredients FORT LAUDERDALE, Fla., Oct. 5, 2023 /PRNewswire/ -- The modern, remote-first work world may not have a consistent nine-to-five rhythm anymore. But that doesn't change the fact that people are still putting a lot of time into working their jobs. The Bureau of Labor Statistics reports that the average American worker clocks in at just over eight hours of labor per day (8.01, to be precise). That means, no matter when those work hours take place, they're going to extend over a significant portion of an individual's daily schedule. It also means it will involve a slump in energy and productivity at some point along the way. "Midday slumps may not always happen in the early afternoon anymore," says Gavin Jacono, founder of Bizz Energy, "But they happen at some point — and on a regular basis. If you start work at four in the morning, chances are you're going to lag after breakfast or in the late morning. If you start at noon, you'll feel tired before dinner." Northwestern Medicine points out that the biggest reason for this energy slump is that it's a predictable part of every individual's circadian cycle. However, the medical site adds that things like sleep disorders, stress, and even poor eating habits can also contribute to a slowdown in the middle of the workday. When that happens, many people turn to energy drinks as a solution — but Jacono points out that traditional energy drink formulas don't really solve the problem. "Those classic formulas use sugar, high fructose corn syrup, or aspartame. They give you a quick boost, but it's often followed by a crash — usually before your work day ends, which only means you're kicking the productivity issue down the road. And your body has to work through all of those unhealthy chemicals and additives, too. That's why we created Bizz Energy. To turn unhealthy, short-term energy drinks into healthy, long-term productivity and health solutions." Bizz Energy replaces unwanted ingredients with healthy alternatives. Each 12 oz can contains a clean shot of 200 mg of caffeine along with a punchy nutritional combination called the SuperTurk® blend. This includes an innovative soluble form of Turkesterone along with creatine, essential amino acids, L-citrulline, L-theanine, L-carnitine, niacin, and biotin. The result of this revolutionary combination is an energy drink that doubles as a nutritional supplement. It helps boost energy without a sugar crash while also stimulating metabolism and helping build muscle and strength. This makes it a clean, mean way to beat a midday slump — no matter when it might take place. About Bizz Energy Bizz Energy was founded by Gavin Jacono. The fitness and nutrition fanatic hails from New York City and is obsessed with boxing, weightlifting, and soccer. As an aspiring 17-year-old entrepreneur, Jacono launched Bizz Energy as a way to create the ultimate energy drink he had always wanted to fuel his athletic pursuits. Along with a potent dose of caffeine, the Bizz Energy formula taps into a unique form of soluble Turkesterone. It is delicious, clean, and effective. Learn more at bizzenergy.com. Media Contact: Gavin Jacono 516-637-8701 [email protected] SOURCE Bizz Energy

04 Aug 2023

·www.prnewswire.com

Bizz Energy Clears Minds and Sharpens Focus

The Clean, Zero-Sugar Energy Drink Is Good For More Than Just Physical Performance. It Boosts Brain Function, Too. FORT LAUDERDALE, Fla., Aug. 4, 2023 /PRNewswire/ -- Bizz Energy is a revolutionary new zero-sugar energy drink designed to boost performance through natural ingredients without the use of harmful chemicals or additives. While this is primarily focused on physical activities, the energy supplement's ingredients can also deliver some helpful benefits for the brain. "I designed Bizz Energy to clear my mind as well as boost my physical performance," explains company founder Gavin Jacono. "Sometimes you need to do more than run faster, lift more, or stay awake longer. Sometimes you need that sharp focus that helps you deliver at work or in school." Bizz Energy helps with cognitive function through multiple natural ingredients. For instance, creatine is a safe brain and body amino acid that has been connected to short-term memory improvement when administered orally. L-citrulline has clearly demonstrated benefits for brain function, as well. L-Theanine relieves stress disorders, improves mood, and helps with sleep. Another ingredient with the potential to help with cognition is Turkesterone. While this popular supplement is currently trending in the sports and fitness world for its physical benefits, there are also suggestions that it could aid mental health by helping cope with stress and fatigue. "Including Turkesterone was a big deal for us," says Jacono. "I knew we wanted it in there, but it's a plant-based steroid, so it isn't water-soluble. We invested in extensive research and testing and were able to develop a method to solubilize Turkesterone — it's one of the most unique things about our product." From carefully selected amino acids to soluble Turkesterone, Bizz Energy is packed with natural ingredients designed to deliver a critical dose of energy when needed. The innovative combination of natural ingredients doesn't just apply to physical performance, either. It can be a game-changer when it comes to cognitive function, too, helping to sharpen the mind and create clear focus. About Bizz Energy Bizz Energy was founded by Gavin Jacono. The fitness and nutrition fanatic hails from New York City and is obsessed with boxing, weightlifting, and soccer. As an aspiring 17-year-old entrepreneur, Jacono launched Bizz Energy as a way to create the ultimate energy drink he had always wanted to fuel his athletic pursuits. Along with a potent dose of caffeine, the Bizz Energy formula taps into a unique form of soluble Turkesterone. It is delicious, clean, and effective. Learn more at bizzenergy.com. Media Contact: Gavin Jacono 516-637-8701 [email protected] SOURCE Bizz Energy

17 Apr 2023

·www.prnewswire.com

Bodybuilding.com™, Leader in Sports Nutrition and Fitness, Announces 'New Era' with Sports Performance Supplement Line

NEW YORK,/PRNewswire/ -- Bodybuilding.com™, the original online sports nutrition ecommerce brand, is proud to announce their new performance supplement line, Elite. The creation of Elite serves as an extension of the brand's private label offering, including the original Signature Series, which was reformulated, rebranded, and relaunched in 2018. While Signature continues to fuel the fitness industry with high quality ingredients at an affordable price, Elite ups the ante with its Informed Sport Certification, allowing athletes everywhere to consume products that have been third-party tested. Continue Reading Welcome to Elite, by Bodybuilding.com Welcome to Elite, by Bodybuilding.com "When our customers asked for elevated performance products, Bodybuilding.com listened," said April Schatschneider, Executive Vice President, Bodybuilding.com. "We are thrilled to deliver our consumers a new, advanced option with Elite. Each product in the line has effective formulas, proven ingredients, and is Informed Choice Sport certified." Bodybuilding.com debuts the line with Elite Ultimate Pre-Workout Stim-Free, formulated with two scientifically researched and trademarked ingredients while offering a caffeine-free alternative for a pre-movement mix. The product is designed to prepare the body and mind for training without stimulants, making it easily stackable with other supplements. It also combines Citrulline and Beta-Alanine to support blood flow and endurance, allowing athletes participating in all modalities to consume before training. Elite Ultimate Pre-Workout Stim-Free features a fan favorite flavor, Rocket Pop, and is available for $39.99 for 24 servings. The new line pairs with Bodybuilding.com's "New Era" campaign, a stake in the ground announcing their transition from predominantly serving the bodybuilding community to a fitness lifestyle brand. This year also marks their 24th year in business. Bodybuilding.com™ continues to serve the fitness community with top tier products and content to help millions reach their health and wellness goals. The brand has also debuted its new tagline; Build your body. Build your mind. Build your life, a nod to the mind body connection equating to an emphasis on longevity. "Bodybuilding.com isn't just for bodybuilders," said Danielle Bitts, Vice President of Brand & Creative. Our mission is to provide our audience with accredited resources to help them build their body for whatever goal they set their sights on. From programs and articles, to supplements and gear, every part of your routine starts here and we couldn't be prouder to be entering our 24th year." The legacy brand provides year round access to new and timely article content, access to thousands of workouts in their training app, BodyFit®, and engages with 13.2 million plus users across social media daily. Bodybuilding.com will continue to evolve efforts to help people everywhere live a healthier, longer life through movement, nutrition, and supplementation education. About Bodybuilding.com Bodybuilding.com is the leading and longest-running digital destination for elite fitness, enabling millions upon millions to build their ideal bodies. As the first fitness platform combining content, community, and commerce, Bodybuilding.com is dedicated to enabling fitness as a life journey. Bodybuilding.com has incubated and cultivated industry-defining brands with products and programming that helped shape today's industry. Bodybuilding.com offers Signature Series and top brand supplements, performance activewear and gear, BodyFit® Membership, fitness apps, an extensive exercise database with detailed instructions and video, a supportive global community, and award-winning customer service. 12 times Bizrate Circle of Excellence for Customer Service and 2019 Digiday Publishing Award for Best Paid Subscription/Membership Product. Download the BodyFit® app today. For media inquiries, contact: Bodybuilding.com 9169 West State Street, #510 Boise, Idaho 83714 866-236-8417 [email protected] SOURCE Bodybuilding.com

100 Deals associated with L-Citrulline

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KEGG	Wiki	ATC	Drug Bank
D07706	L-Citrulline	-	-

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Lung Injury	Phase 3	AT	Asklepion Pharmaceuticals LLC	01 Aug 2016
Acute Lung Injury	Phase 3	IL	Asklepion Pharmaceuticals LLC	01 Aug 2016
Acute Lung Injury	Phase 3	DE	Asklepion Pharmaceuticals LLC	01 Aug 2016
Acute Lung Injury	Phase 3	DE	Asklepion Pharmaceuticals LLC	01 Aug 2016
Acute Lung Injury	Phase 3	IL	Asklepion Pharmaceuticals LLC	01 Aug 2016
Acute Lung Injury	Phase 3	US	Asklepion Pharmaceuticals LLC	01 Aug 2016
Acute Lung Injury	Phase 3	AT	Asklepion Pharmaceuticals LLC	01 Aug 2016
Acute Lung Injury	Phase 3	US	Asklepion Pharmaceuticals LLC	01 Aug 2016
Heart Defects, Congenital	Phase 3	US	Asklepion Pharmaceuticals LLC	01 May 2006
Hypertension, Pulmonary	Phase 3	US	Asklepion Pharmaceuticals LLC	01 May 2006

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04570384 (CTgov)	Phase 2	Hypoxic respiratory failure \| COVID-19 \| COVID-19 respiratory infection	65	L-Citrulline (IV L-Citrulline (Turnobi) Arm)	xonxqhdsje(uyrxjrbelt) = ifuplgcevw nkewsgemkf (gfmchnpmsc, dfwizxsobd - wnbhradkce) View more	-	22 Feb 2023
				Placebo (Placebo Arm)	xonxqhdsje(uyrxjrbelt) = tdxsfvifgz nkewsgemkf (gfmchnpmsc, kjphipxuol - uuoawiywhl) View more
NCT03542812 (Pubmed)	Early Phase 1	Bronchopulmonary Dysplasia \| Pulmonary Arterial Hypertension	16	L-Citrulline	(pvwrrtzjmm) = caqumjezdu omdbxntnzd (kerjeuzfsg ) View more	-	31 Oct 2022
NCT01120964 (CTgov)	Phase 1/2	Atrioventricular Septal Defect \| Heart Septal Defects, Atrial \| Heart Septal Defects, Ventricular	22	Intravenous L-Citrulline (Intravenous L-Citrulline)	dkfcudbojc(utqflvejeg) = qcnmixudju qoyevwnyby (lnawwzbbfm, zttmmbhyac - zqsdgtgcwh) View more	-	21 Jun 2022
				Placebo of Intravenous L-Citrulline (Placebo of Intravenous L-Citrulline)	dkfcudbojc(utqflvejeg) = euttwxfdrj qoyevwnyby (lnawwzbbfm, waesmoarde - sotgxmctbt) View more
NCT01386034 (Pubmed \| Clin Nutr)	Phase 3	Short Bowel Syndrome	9	Citrulline supplementation	nidimlonrk(trwyddegzw) = wvftndzfqn gtmdefylib (cxdnchvklk ) View more	-	01 Dec 2019
				citrulline (Placebo)	nidimlonrk(trwyddegzw) = adlqnmhuhf gtmdefylib (cxdnchvklk ) View more
NCT02697240 (CTgov)	Phase 1	Vaso-occlusive crisis \| Acute Chest Syndrome	4	Intravenous citrulline	mwceuhzuav(iahzutmkah) = hjhkkniraj dwiwfjwtie (binsbfltut, bzrrarqcun - lyscycoxbi) View more	-	17 Apr 2019
NCT01474863 (CTgov)	Phase 2	Acute Lung Injury \| Sepsis	72	Low Dose Citrulline (Low Dose Citrulline)	ihyubxumoh(lpjesgiuta) = utynvstcpt zfvivfrcqz (rwnhugbkqr, axlvxikvqb - ovgibcoohb) View more	-	05 Jun 2017
				Placebo (Placebo)	ihyubxumoh(lpjesgiuta) = aasehkurzi zfvivfrcqz (rwnhugbkqr, drkcndgavf - othshesslc) View more
NCT02314689 (CTgov)	Phase 1	Anemia, Sickle Cell	4	Intravenous (IV) citrulline	qomjzconeb(qpdqctcyxl) = rlbdtiwywa gthjkrylpk (cdebfieqbx, vxvpwvnlfu - rgtukafrbo)	-	07 Mar 2016
Pubmed \| J Nutr	Not Applicable	Fetal Growth Retardation	-	L-Citrulline	xsertehqld(qaxzpzxkwm) = dxuattcthx qaogptojys (llpbbbsfqx )	-	01 Mar 2016
				L-Citrulline	xsertehqld(qaxzpzxkwm) = fxphrlcped qaogptojys (llpbbbsfqx )

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