HealthyPhase 1NCT01061554
Bioavailability Study of Long Chain Omega-3 Fatty Acids From a Gastric Stable Emulsion
A Phase 1 study testing Omega-3 oils from tri-glycerides and Omega-3 oils from marine phospholipids in people with Healthy, run by Ayanda AS at 1 site in Norway.
Trial summary
The purpose of this study is to compare the short term absorption of EPA and DHA from triglycerides (TG) released from normal soft gel capsules and from the new patent pending vehicle providing a gastric stable emulsion. Read more about this study
- Who is it for?
- Ages 19 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Omega-3 oils from tri-glycerides and Omega-3 oils from marine phospholipids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2009to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 19 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Student at Nord-Trondelag University College
- Healthy (no known condition)
- Males and females aged 19 to 29 years
Who cannot join
- Fish allergies
- Ongoing consumption of omega-3 fatty acids
- Subjects receiving anticoagulation or non-steroid anti-inflammatory treatment
- Subjects with a known metabolic syndrome; diabetes, hypercholesterol, hypertension, obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Level of Polyunsaturated Fatty Acid EPA and DHA in Blood After Digestion of ProBios Omega-3 Concordix™ Compared With Omega-3 Soft Capsules - a Pilot
The purpose of this study is to compare the short term absorption of EPA and DHA from triglycerides (TG) released from normal soft gel capsules and from the new patent pending vehicle providing a gastric stable emulsion.
Read the detailed description
The present study comprises the design of as well as the effect of pre-emulsification of ω-3 fatty acids on the bioavailability of docosahexaenoic acid and eicosapentaenoic acid. In-vitro studies have shown that long-term steric stabilization of an o/w-emulsion is obtained by arresting the oil droplets in a gelatin continuous gel matrix. The emulsion was also stable upon dissolution of the gel matrix at physiological conditions in-vitro and is hence referred to as a gastric stable emulsion (GSE).
In the bioavailability study, healthy young students were recruited and presented two different single-dose treatments of fish oil containing 5 grams of ω-3 fatty acids; one group receiving the fatty acids in traditional soft gel capsules, whereas the other group received the fatty acids using the GSE technology. Time resolved (2 - 26 hours) blood plasma analysis after intake of this single dose ω-3 fatty acids revealed significantly increased AUC0-26h and Cmax of EPA and EPA + DHA when administered as GSE compared to traditional soft gel capsules.
- Conditions
- Healthy
- Being tested
- Omega-3 oils from tri-glycerides, Omega-3 oils from marine phospholipids
- Keywords
- Bioavailability, Eicosapentaenoic acid, Docosahexaenoic acid, Soft gel capsules, Gastric stable emulsion, Omega-3, Tri-glycerides, Marine phospholipids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 oils from tri-glyceridesDietary supplement
Single-dose administration of approximately 5 grams of omega-3 oils from triglycerides
Omega-3 oils from marine phospholipidsDietary supplement
Single-dose administration of approximately 5 grams of omega-3 oils from marine phospholipids
| Study group | Role | What they receive |
|---|---|---|
| Gastric stable emulsion | Experimental | A gastric stable emulsion vehicle for administration of tri-glyceride based omega-3 oils Receives: Dietary Supplement: Omega-3 oils from tri-glycerides |
| Soft gel capsule (TG) | Active comparator | Soft gel capsule for administration of tri-glyceride based omega-3 oils Receives: Dietary Supplement: Omega-3 oils from tri-glycerides |
| Soft gel capsules (MPL) | Active comparator | Soft gel capsule for administration of marine phospholipids based omega-3 oils Receives: Dietary Supplement: Omega-3 oils from marine phospholipids |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incremental (change from baseline) area under the blood plasma concentration curve of eicosapentaenoic acid (EPA)
Measured: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The incremental (change from baseline) area under the blood plasma concentration curve of docosahexaenoic acid (DHA)
Measured: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The incremental (change from baseline) area under the blood plasma concentration curve of Vitamin E
Measured: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Secondary outcomes (6)
The maximal incremental blood plasma concentration of EPA
Measured: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The maximal incremental blood plasma concentration of DHA
Measured: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The maximal incremental blood plasma concentration of Vitamin E
Measured: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The time passed since administration at which the incremental plasma concentration maximum occurs for EPA
Measured: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The time passed since administration at which the incremental plasma concentration maximum occurs for DHA
Measured: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The time passed since administration at which the incremental plasma concentration maximum occurs for Vitamin E
Measured: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayanda AS
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061554
- Sponsor's protocol ID
- AYANDA-CC-01
- Status last verified
- Apr 2009
- First submitted
- 2 Feb 2010
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Armand M, Borel P, Dubois C, Senft M, Peyrot J, Salducci J, Lafont H, Lairon D. Characterization of emulsions and lipolysis of dietary lipids in the human stomach. Am J Physiol. 1994 Mar;266(3 Pt 1):G372-81. doi: 10.1152/ajpgi.1994.266.3.G372.
PubMed 8166277Armand M, Borel P, Pasquier B, Dubois C, Senft M, Andre M, Peyrot J, Salducci J, Lairon D. Physicochemical characteristics of emulsions during fat digestion in human stomach and duodenum. Am J Physiol. 1996 Jul;271(1 Pt 1):G172-83. doi: 10.1152/ajpgi.1996.271.1.G172.
PubMed 8760121Armand M, Pasquier B, Andre M, Borel P, Senft M, Peyrot J, Salducci J, Portugal H, Jaussan V, Lairon D. Digestion and absorption of 2 fat emulsions with different droplet sizes in the human digestive tract. Am J Clin Nutr. 1999 Dec;70(6):1096-106. doi: 10.1093/ajcn/70.6.1096.
PubMed 10584056Arterburn LM, Hall EB, Oken H. Distribution, interconversion, and dose response of n-3 fatty acids in humans. Am J Clin Nutr. 2006 Jun;83(6 Suppl):1467S-1476S. doi: 10.1093/ajcn/83.6.1467S.
PubMed 16841856Arterburn LM, Oken HA, Hoffman JP, Bailey-Hall E, Chung G, Rom D, Hamersley J, McCarthy D. Bioequivalence of Docosahexaenoic acid from different algal oils in capsules and in a DHA-fortified food. Lipids. 2007 Nov;42(11):1011-24. doi: 10.1007/s11745-007-3098-5. Epub 2007 Aug 23.
PubMed 17713804Borel P, Pasquier B, Armand M, Tyssandier V, Grolier P, Alexandre-Gouabau MC, Andre M, Senft M, Peyrot J, Jaussan V, Lairon D, Azais-Braesco V. Processing of vitamin A and E in the human gastrointestinal tract. Am J Physiol Gastrointest Liver Physiol. 2001 Jan;280(1):G95-G103. doi: 10.1152/ajpgi.2001.280.1.G95.
PubMed 11123202Bucher HC, Hengstler P, Schindler C, Meier G. N-3 polyunsaturated fatty acids in coronary heart disease: a meta-analysis of randomized controlled trials. Am J Med. 2002 Mar;112(4):298-304. doi: 10.1016/s0002-9343(01)01114-7.
PubMed 11893369Cao J, Schwichtenberg KA, Hanson NQ, Tsai MY. Incorporation and clearance of omega-3 fatty acids in erythrocyte membranes and plasma phospholipids. Clin Chem. 2006 Dec;52(12):2265-72. doi: 10.1373/clinchem.2006.072322. Epub 2006 Oct 19.
PubMed 17053155Elvevoll EO, Barstad H, Breimo ES, Brox J, Eilertsen KE, Lund T, Olsen JO, Osterud B. Enhanced incorporation of n-3 fatty acids from fish compared with fish oils. Lipids. 2006 Dec;41(12):1109-14. doi: 10.1007/s11745-006-5060-3.
PubMed 17269556Elvevoll EO, Eilertsen KE, Brox J, Dragnes BT, Falkenberg P, Olsen JO, Kirkhus B, Lamglait A, Osterud B. Seafood diets: hypolipidemic and antiatherogenic effects of taurine and n-3 fatty acids. Atherosclerosis. 2008 Oct;200(2):396-402. doi: 10.1016/j.atherosclerosis.2007.12.021. Epub 2008 Feb 1.
PubMed 18242615Garaiova I, Guschina IA, Plummer SF, Tang J, Wang D, Plummer NT. A randomised cross-over trial in healthy adults indicating improved absorption of omega-3 fatty acids by pre-emulsification. Nutr J. 2007 Jan 25;6:4. doi: 10.1186/1475-2891-6-4.
PubMed 17254329Grimsgaard S, Bonaa KH, Hansen JB, Myhre ES. Effects of highly purified eicosapentaenoic acid and docosahexaenoic acid on hemodynamics in humans. Am J Clin Nutr. 1998 Jul;68(1):52-9. doi: 10.1093/ajcn/68.1.52.
PubMed 9665096Harris WS. Omega-3 fatty acids and cardiovascular disease: a case for omega-3 index as a new risk factor. Pharmacol Res. 2007 Mar;55(3):217-23. doi: 10.1016/j.phrs.2007.01.013. Epub 2007 Jan 25.
PubMed 17324586Iso H, Kobayashi M, Ishihara J, Sasaki S, Okada K, Kita Y, Kokubo Y, Tsugane S; JPHC Study Group. Intake of fish and n3 fatty acids and risk of coronary heart disease among Japanese: the Japan Public Health Center-Based (JPHC) Study Cohort I. Circulation. 2006 Jan 17;113(2):195-202. doi: 10.1161/CIRCULATIONAHA.105.581355. Epub 2006 Jan 9.
PubMed 16401768Hsu, J. C. (1992). The Factor Analytic Approach to Simultaneous Inference in the General Linear Model. Journal of Computational and Graphical Statistics, 1(2), 151-168.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Level of Polyunsaturated Fatty Acid EPA and DHA in Blood After Digestion of ProBios Omega-3 Concordix™ Compared With Omega-3 Soft Capsules - a Pilot
- ClinicalTrials.gov ID
- NCT01061554
- Acronym / sponsor ID
- AYANDA-CC-01
- Conditions
- Healthy
- Keywords
- Bioavailability, Eicosapentaenoic acid, Docosahexaenoic acid, Soft gel capsules, Gastric stable emulsion, Omega-3, Tri-glycerides, Marine phospholipids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ayanda ASIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Feb 2010 (estimated)
- 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.
The purpose of this study is to compare the short term absorption of EPA and DHA from triglycerides (TG) released from normal soft gel capsules and from the new patent pending vehicle providing a gastric stable emulsion.
Detailed description
The present study comprises the design of as well as the effect of pre-emulsification of ω-3 fatty acids on the bioavailability of docosahexaenoic acid and eicosapentaenoic acid. In-vitro studies have shown that long-term steric stabilization of an o/w-emulsion is obtained by arresting the oil droplets in a gelatin continuous gel matrix. The emulsion was also stable upon dissolution of the gel matrix at physiological conditions in-vitro and is hence referred to as a gastric stable emulsion (GSE).
In the bioavailability study, healthy young students were recruited and presented two different single-dose treatments of fish oil containing 5 grams of ω-3 fatty acids; one group receiving the fatty acids in traditional soft gel capsules, whereas the other group received the fatty acids using the GSE technology. Time resolved (2 - 26 hours) blood plasma analysis after intake of this single dose ω-3 fatty acids revealed significantly increased AUC0-26h and Cmax of EPA and EPA + DHA when administered as GSE compared to traditional soft gel capsules.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric stable emulsion | Experimental | Dietary Supplement: Omega-3 oils from tri-glyceridesA gastric stable emulsion vehicle for administration of tri-glyceride based omega-3 oils |
| Soft gel capsule (TG) | Active comparator | Dietary Supplement: Omega-3 oils from tri-glyceridesSoft gel capsule for administration of tri-glyceride based omega-3 oils |
| Soft gel capsules (MPL) | Active comparator | Dietary Supplement: Omega-3 oils from marine phospholipidsSoft gel capsule for administration of marine phospholipids based omega-3 oils |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Student at Nord-Trondelag University College
- Healthy (no known condition)
- Males and females aged 19 to 29 years
Key exclusion criteria (4 listed)
- Fish allergies
- Ongoing consumption of omega-3 fatty acids
- Subjects receiving anticoagulation or non-steroid anti-inflammatory treatment
- Subjects with a known metabolic syndrome; diabetes, hypercholesterol, hypertension, obesity
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 oils from tri-glyceridesSingle-dose administration of approximately 5 grams of omega-3 oils from triglycerides | Dietary supplement | Gastric stable emulsion, Soft gel capsule (TG) |
| Omega-3 oils from marine phospholipidsSingle-dose administration of approximately 5 grams of omega-3 oils from marine phospholipids | Dietary supplement | Soft gel capsules (MPL) |
Primary outcome
The incremental (change from baseline) area under the blood plasma concentration curve of eicosapentaenoic acid (EPA)
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The incremental (change from baseline) area under the blood plasma concentration curve of docosahexaenoic acid (DHA)
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The incremental (change from baseline) area under the blood plasma concentration curve of Vitamin E
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
6 secondary outcomes
The maximal incremental blood plasma concentration of EPA
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The maximal incremental blood plasma concentration of DHA
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The maximal incremental blood plasma concentration of Vitamin E
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The time passed since administration at which the incremental plasma concentration maximum occurs for EPA
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The time passed since administration at which the incremental plasma concentration maximum occurs for DHA
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The time passed since administration at which the incremental plasma concentration maximum occurs for Vitamin E
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
- Background: PubMed 8166277Armand M, Borel P, Dubois C, Senft M, Peyrot J, Salducci J, Lafont H, Lairon D. Characterization of emulsions and lipolysis of dietary lipids in the human stomach. Am J Physiol. 1994 Mar;266(3 Pt 1):G372-81. doi: 10.1152/ajpgi.1994.266.3.G372.
- Background: PubMed 8760121Armand M, Borel P, Pasquier B, Dubois C, Senft M, Andre M, Peyrot J, Salducci J, Lairon D. Physicochemical characteristics of emulsions during fat digestion in human stomach and duodenum. Am J Physiol. 1996 Jul;271(1 Pt 1):G172-83. doi: 10.1152/ajpgi.1996.271.1.G172.
- Background: PubMed 10584056Armand M, Pasquier B, Andre M, Borel P, Senft M, Peyrot J, Salducci J, Portugal H, Jaussan V, Lairon D. Digestion and absorption of 2 fat emulsions with different droplet sizes in the human digestive tract. Am J Clin Nutr. 1999 Dec;70(6):1096-106. doi: 10.1093/ajcn/70.6.1096.
- Background: PubMed 16841856Arterburn LM, Hall EB, Oken H. Distribution, interconversion, and dose response of n-3 fatty acids in humans. Am J Clin Nutr. 2006 Jun;83(6 Suppl):1467S-1476S. doi: 10.1093/ajcn/83.6.1467S.
- Background: PubMed 17713804Arterburn LM, Oken HA, Hoffman JP, Bailey-Hall E, Chung G, Rom D, Hamersley J, McCarthy D. Bioequivalence of Docosahexaenoic acid from different algal oils in capsules and in a DHA-fortified food. Lipids. 2007 Nov;42(11):1011-24. doi: 10.1007/s11745-007-3098-5. Epub 2007 Aug 23.
- Background: PubMed 11123202Borel P, Pasquier B, Armand M, Tyssandier V, Grolier P, Alexandre-Gouabau MC, Andre M, Senft M, Peyrot J, Jaussan V, Lairon D, Azais-Braesco V. Processing of vitamin A and E in the human gastrointestinal tract. Am J Physiol Gastrointest Liver Physiol. 2001 Jan;280(1):G95-G103. doi: 10.1152/ajpgi.2001.280.1.G95.
- Background: PubMed 11893369Bucher HC, Hengstler P, Schindler C, Meier G. N-3 polyunsaturated fatty acids in coronary heart disease: a meta-analysis of randomized controlled trials. Am J Med. 2002 Mar;112(4):298-304. doi: 10.1016/s0002-9343(01)01114-7.
- Background: PubMed 17053155Cao J, Schwichtenberg KA, Hanson NQ, Tsai MY. Incorporation and clearance of omega-3 fatty acids in erythrocyte membranes and plasma phospholipids. Clin Chem. 2006 Dec;52(12):2265-72. doi: 10.1373/clinchem.2006.072322. Epub 2006 Oct 19.
- Background: PubMed 17269556Elvevoll EO, Barstad H, Breimo ES, Brox J, Eilertsen KE, Lund T, Olsen JO, Osterud B. Enhanced incorporation of n-3 fatty acids from fish compared with fish oils. Lipids. 2006 Dec;41(12):1109-14. doi: 10.1007/s11745-006-5060-3.
- Background: PubMed 18242615Elvevoll EO, Eilertsen KE, Brox J, Dragnes BT, Falkenberg P, Olsen JO, Kirkhus B, Lamglait A, Osterud B. Seafood diets: hypolipidemic and antiatherogenic effects of taurine and n-3 fatty acids. Atherosclerosis. 2008 Oct;200(2):396-402. doi: 10.1016/j.atherosclerosis.2007.12.021. Epub 2008 Feb 1.
- Background: PubMed 17254329Garaiova I, Guschina IA, Plummer SF, Tang J, Wang D, Plummer NT. A randomised cross-over trial in healthy adults indicating improved absorption of omega-3 fatty acids by pre-emulsification. Nutr J. 2007 Jan 25;6:4. doi: 10.1186/1475-2891-6-4.
- Background: PubMed 9665096Grimsgaard S, Bonaa KH, Hansen JB, Myhre ES. Effects of highly purified eicosapentaenoic acid and docosahexaenoic acid on hemodynamics in humans. Am J Clin Nutr. 1998 Jul;68(1):52-9. doi: 10.1093/ajcn/68.1.52.
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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. This study is not recruiting at the moment.
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 Phase 1 study testing Omega-3 oils from tri-glycerides and Omega-3 oils from marine phospholipids in people with Healthy, run by Ayanda AS at 1 site in Norway.
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 3 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: finished, as of the sponsor's last update on 3 Feb 2010. 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 Norway. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incremental (change from baseline) area under the blood plasma concentration curve of eicosapentaenoic acid (EPA) (time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)). The study lists 3 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 NCT01061554, which also lists 31 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 3 Feb 2010.