Micronutrient DeficienciesPhase 2MDEG2-PSTNCT03431597
Effectiveness of a Micronutrient Supplement to Lower Plasma Homocysteine MDEG2 Pilot Supplementation Trial
A Phase 2 study testing novel micronutrient and existing micronutrient supplement, UNIMMAP in people with Micronutrient Deficiencies and Hyperhomocysteinemia, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
This micronutrient supplementation study is a 3-arm randomized controlled trial, unblinded, with 125 women per arm. Non-pregnant, non-lactating healthy women of reproductive age in West Kiang, The Gambia, will be randomized to 12 weeks of daily supplementation of either a) novel micronutrient supplement, b) a United… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Micronutrient Deficiencies, Hyperhomocysteinemia
- What is being tested?
- novel micronutrient and existing micronutrient supplement, UNIMMAP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteThe Gambia
- Study dates
- 26 Apr 2018to 26 Nov 2018
- Phase
- Phase 2
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pre-menopausal women aged 18-45 years
- Non-pregnant, confirmed by pregnancy urine test at eligibility screen
- Non-lactating (at least 9 months post-partum)
- No plan to conceive in the ensuing 3 months, asked verbally by field worker
- No plans to travel
- Healthy with no current illness and no chronic health problems, asked verbally by field worker
Who cannot join
- Known history of chronic illness (particularly cardiovascular disease, renal disease, thyroid disease, cancer)
- Taking B vitamin or multivitamin supplements.
- Taking medication for prevention of seizures (e.g. Carbamazepine).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Micronutrient Supplement to Lower Plasma Homocysteine in Non-pregnant Women of Reproductive Age
This micronutrient supplementation study is a 3-arm randomized controlled trial, unblinded, with 125 women per arm. Non-pregnant, non-lactating healthy women of reproductive age in West Kiang, The Gambia, will be randomized to 12 weeks of daily supplementation of either a) novel micronutrient supplement, b) a United Nations International Multiple Micronutrient Preparation (UNIMMAP) tablet or c) no intervention (control). The novel micronutrient supplement is a drink powder providing 800 µg folic acid, 5.2 µg cyanocobalamin (B12), 2.8 mg Riboflavin-5'-phosphate (B2), and 4g trimethylglycine (betaine). UNIMMAP contains 15 micronutrients at the Recommended Daily Allowance level. The aim is to test the effectiveness of the supplements on correcting micronutrient deficiencies in the dry season and to reduce homocysteine levels. The hypothesis is that the new drink powder will be the most effective supplement, causing a reduction in 1 µmol/L compared to the control group after supplementation.
The supplements will be supplied to participants on a daily basis by Community-based Birth Attendants (CBCs). The CBCs will observe consumption of the supplement. The novel micronutrient supplement will be provided in powder form with instructions to dissolve one sachet in a cup of 200ml water. UNIMMAP will be provided in capsule form to be taken with water. Women will provide one 10ml fasted venous blood sample at baseline and another after 6 and 12 weeks of supplementation. At each time point they will also have their blood pressure and anthropometry assessed and provide a urine pregnancy test.
Correcting micronutrient deficiencies is extremely important for the long-term health of women, and in particular around the time of conception and throughout pregnancy since micronutrients are needed for the proper physical and cognitive development of the baby. Certain micronutrients are required for adding a methyl group to places on DNA ('DNA methylation'). The pattern of these methyl groups can help determine whether a gene is switched on or off. Correct functioning of DNA methylation processes is therefore of critical importance for fetal development. High levels of homocysteine can impede DNA methylation, therefore supplements that reduce homocysteine may not only be beneficial for the mother but also for the developing child. The most effective supplement in this trial will be considered for testing in larger pregnancy trials.
Read the detailed description
In rural Gambia women experience considerable variation in their diet by season. In the dry season women have particular micronutrient deficiencies that can disrupt one-carbon metabolism pathways. In the dry season women have lower levels of most of the B vitamins and higher levels of homocysteine compared to the rainy season. The goal of this trial is to test two nutritional interventions to see which one works best in providing micronutrients in the ratio and quantity necessary for optimal 1-carbon metabolism in the dry season. The primary end point is to assess which supplement is most effective in reducing plasma homocysteine.
This is a 3-arm randomized controlled trial, unblinded, with 125 women per arm. Non-pregnant, non-lactating healthy women of reproductive age in West Kiang will be randomized to 12 weeks of daily supplementation of either a) novel micronutrient drink powder supplement, b) existing available micronutrient supplement (UNIMMAP) or c) no intervention (control). The novel drink powder provides 800 µg folic acid, 5.2 µg cyanocobalamin (B12), 2.8 mg Riboflavin-5'-phosphate (B2), and 4g trimethylglycine (betaine). This dose is twice the Recommended Daily Allowance for folic acid, B12 and B2. The UNIMMAP tablet provides 15 micronutrients (vitamins A, D, E, B1, B2, B6, B12, C, Niacin, Folic Acid, Iron, Zinc, Copper, Iron, Selenium) at the Recommended Daily Allowance level.
Potentially eligible participants will be identified through the Keneba Health and Demographic Surveillance System in all 35 villages of West Kiang region of The Gambia. Field assistants will visit the homes of potentially eligible participants to provide full information about the purpose and methods of the study, potential risks and benefits, and participants' rights. Full inclusion and exclusion criteria will be assessed. Participants will then be asked to provide a signed or thumb-printed informed consent before being enrolled into the study.
The supplements will be supplied to participants on a daily basis by Community-based Birth Companions (CBCs). The novel drink powder will be provided in daily sachets and dissolved in 200ml water. UNIMMAP will be provided in capsule form to be taken with water. The CBCs will observe consumption of the supplement. Participants will be given 7 coloured cards at the start of each week. Every day they will give the CBC one card and receive their supplement. Each week a field assistant will collect data on compliance by recording card collection in liaison with the CBC.
Women will provide one 10mL fasted venous blood sample at baseline and another after 6 and 12 weeks of supplementation. At each time point they will also have their blood pressure and anthropometry (weight and height) assessed and provide a urine pregnancy test. Women will be brought to the Medical Research Council Gambia (MRCG) field station at Keneba for the baseline, 6 week (mid-line) and 12 week (end-line) data collection visits. Participants will be followed-up after the intervention period for a further 3 weeks to monitor any adverse effects.
The fasted 10mL baseline, 6 week and 12 week blood samples will be taken by venepuncture into EDTA monovettes and kept on ice. Within one hour of collection the samples will be processed by the laboratory in Keneba to centrifuge the samples, separate the plasma and store plasma and red blood cell aliquots at -70°C. One plasma aliquot will be analysed in Keneba to measure homocysteine using the Cobas Integra 400 Plus analyser.
The hypothesis is that the novel micronutrient supplement will reduce plasma by at least 1 µmol/L compared to the control group after 12 weeks of daily supplementation. It will be more effective in reducing plasma homocysteine than existing UNIMMAP tablets.
This trial is powered to study to detect a decrease of 1 µmol/L homocysteine with 80% power and 95% confidence. The trial statistician will use a linear regression model to determine the mean difference between intervention and control homocysteine at 12 weeks adjusted for baseline homocysteine, week 12 age and week 12 body mass index.
- Conditions
- Micronutrient Deficiencies, Hyperhomocysteinemia
- Being tested
- novel micronutrient, existing micronutrient supplement, UNIMMAP
- Medical subject headings
- Hyperhomocysteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel micronutrientDietary supplement
The supplements will be supplied to participants on a daily basis. The novel micronutrient supplement will be provided in powder form with instructions to dissolve one sachet in 250ml of clean water
existing micronutrient supplement, UNIMMAPDietary supplement
UNIMMAP will be provided in tablet form and given one daily
| Study group | Role | What they receive |
|---|---|---|
| oral nutritional supplementation | Experimental | Daily novel micronutrient supplement: 800 μg folic acid, 5.2 μg cyanocobalamin (B12), 2.8 mg Riboflavin-5'- phosphate (B2), 4g trimethylglycine (betaine) in drink powder form. The drink will be dissolved in 200ml of water and taken daily for 12 weeks Receives: Dietary Supplement: novel micronutrient |
| oral nutritional supplementation, UNIMMAP | Active comparator | The United Nations Multiple Micronutrient Preparation (UNIMMAP) supplement is a capsule containing 15 micronutrients (vitamins A, D, E, B1, B2, B6, B12, C, Niacin, Folic Acid, Fe, Zn, Cu, I, Se) at the Recommended Daily Allowance level. UNIMMAP will be provided in capsule form and taken daily with water for 12 weeks. Receives: Dietary Supplement: existing micronutrient supplement, UNIMMAP |
| control | No intervention | no treatment will be given to this group observation only (no placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in plasma homocysteine concentration between the drink powder and control arms at end-lineplasma Hcy vs control
To compare the effect of a novel micronutrient supplement taken daily for 12 weeks in the dry season on lowering plasma homocysteine versus the control group supplement taken daily for 12 weeks in the dry season on lowering plasma homocysteine (Hcy) versus the control group
Measured: after 12 weeks
Secondary outcomes (3)
Difference in plasma homocysteine concentration between the drink powder and UNIMMAP arms at end-line
To compare the effect of a novel micronutrient supplement taken daily for 12 weeks in the dry season on lowering plasma homocysteine versus the UNIMMAP group.
Measured: after 12 weeks
Difference in plasma homocysteine concentration between the the drink powder and UNIMMAP arms at mid-line
To compare the effect of a novel micronutrient supplement taken daily for 6 weeks in the dry season on lowering plasma homocysteine versus the UNIMMAP group
Measured: after 6 weeks
Difference in blood pressure (systolic and diastolic) and pulse between the drink powder and control arms at end-line
To compare the effect of a novel micronutrient supplement taken daily for 12 weeks in the dry season on lowering blood pressure and pulse versus the control group
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start26 Apr 2018
- Primary completion20 Jul 2018
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Micronutrient DeficienciesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-arm randomized controlled trial, unblinded, with 125 women per arm.
- Masking
- None (open label)
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Prentice, PhD, Principal investigator, Medical Research Council Unit, The Gambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431597
- Sponsor's protocol ID
- SCC 1575
- Acronym
- MDEG2-PST
- Status last verified
- Jan 2019
- First submitted
- 26 Jan 2018
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
James PT, Jawla O, Mohammed NI, Ceesay K, Akemokwe FM, Sonko B, Sise EA, Prentice AM, Silver MJ. A novel nutritional supplement to reduce plasma homocysteine in nonpregnant women: A randomised controlled trial in The Gambia. PLoS Med. 2019 Aug 13;16(8):e1002870. doi: 10.1371/journal.pmed.1002870. eCollection 2019 Aug.
PubMed 31408467
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Micronutrient Supplement to Lower Plasma Homocysteine in Non-pregnant Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT03431597
- Acronym / sponsor ID
- MDEG2-PST / SCC 1575
- Conditions
- Micronutrient Deficiencies, Hyperhomocysteinemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 13 Feb 2018 (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 micronutrient supplementation study is a 3-arm randomized controlled trial, unblinded, with 125 women per arm. Non-pregnant, non-lactating healthy women of reproductive age in West Kiang, The Gambia, will be randomized to 12 weeks of daily supplementation of either a) novel micronutrient supplement, b) a United Nations International Multiple Micronutrient Preparation (UNIMMAP) tablet or c) no intervention (control). The novel micronutrient supplement is a drink powder providing 800 µg folic acid, 5.2 µg cyanocobalamin (B12), 2.8 mg Riboflavin-5'-phosphate (B2), and 4g trimethylglycine (betaine). UNIMMAP contains 15 micronutrients at the Recommended Daily Allowance level. The aim is to test the effectiveness of the supplements on correcting micronutrient deficiencies in the dry season and to reduce homocysteine levels. The hypothesis is that the new drink powder will be the most effective supplement, causing a reduction in 1 µmol/L compared to the control group after supplementation.
The supplements will be supplied to participants on a daily basis by Community-based Birth Attendants (CBCs). The CBCs will observe consumption of the supplement. The novel micronutrient supplement will be provided in powder form with instructions to dissolve one sachet in a cup of 200ml water. UNIMMAP will be provided in capsule form to be taken with water. Women will provide one 10ml fasted venous blood sample at baseline and another after 6 and 12 weeks of supplementation. At each time point they will also have their blood pressure and anthropometry assessed and provide a urine pregnancy test.
Correcting micronutrient deficiencies is extremely important for the long-term health of women, and in particular around the time of conception and throughout pregnancy since micronutrients are needed for the proper physical and cognitive development of the baby. Certain micronutrients are required for adding a methyl group to places on DNA ('DNA methylation'). The pattern of these methyl groups can help determine whether a gene is switched on or off. Correct functioning of DNA methylation processes is therefore of critical importance for fetal development. High levels of homocysteine can impede DNA methylation, therefore supplements that reduce homocysteine may not only be beneficial for the mother but also for the developing child. The most effective supplement in this trial will be considered for testing in larger pregnancy trials.
Detailed description
In rural Gambia women experience considerable variation in their diet by season. In the dry season women have particular micronutrient deficiencies that can disrupt one-carbon metabolism pathways. In the dry season women have lower levels of most of the B vitamins and higher levels of homocysteine compared to the rainy season. The goal of this trial is to test two nutritional interventions to see which one works best in providing micronutrients in the ratio and quantity necessary for optimal 1-carbon metabolism in the dry season. The primary end point is to assess which supplement is most effective in reducing plasma homocysteine.
This is a 3-arm randomized controlled trial, unblinded, with 125 women per arm. Non-pregnant, non-lactating healthy women of reproductive age in West Kiang will be randomized to 12 weeks of daily supplementation of either a) novel micronutrient drink powder supplement, b) existing available micronutrient supplement (UNIMMAP) or c) no intervention (control). The novel drink powder provides 800 µg folic acid, 5.2 µg cyanocobalamin (B12), 2.8 mg Riboflavin-5'-phosphate (B2), and 4g trimethylglycine (betaine). This dose is twice the Recommended Daily Allowance for folic acid, B12 and B2. The UNIMMAP tablet provides 15 micronutrients (vitamins A, D, E, B1, B2, B6, B12, C, Niacin, Folic Acid, Iron, Zinc, Copper, Iron, Selenium) at the Recommended Daily Allowance level.
Potentially eligible participants will be identified through the Keneba Health and Demographic Surveillance System in all 35 villages of West Kiang region of The Gambia. Field assistants will visit the homes of potentially eligible participants to provide full information about the purpose and methods of the study, potential risks and benefits, and participants' rights. Full inclusion and exclusion criteria will be assessed. Participants will then be asked to provide a signed or thumb-printed informed consent before being enrolled into the study.
The supplements will be supplied to participants on a daily basis by Community-based Birth Companions (CBCs). The novel drink powder will be provided in daily sachets and dissolved in 200ml water. UNIMMAP will be provided in capsule form to be taken with water. The CBCs will observe consumption of the supplement. Participants will be given 7 coloured cards at the start of each week. Every day they will give the CBC one card and receive their supplement. Each week a field assistant will collect data on compliance by recording card collection in liaison with the CBC.
Women will provide one 10mL fasted venous blood sample at baseline and another after 6 and 12 weeks of supplementation. At each time point they will also have their blood pressure and anthropometry (weight and height) assessed and provide a urine pregnancy test. Women will be brought to the Medical Research Council Gambia (MRCG) field station at Keneba for the baseline, 6 week (mid-line) and 12 week (end-line) data collection visits. Participants will be followed-up after the intervention period for a further 3 weeks to monitor any adverse effects.
The fasted 10mL baseline, 6 week and 12 week blood samples will be taken by venepuncture into EDTA monovettes and kept on ice. Within one hour of collection the samples will be processed by the laboratory in Keneba to centrifuge the samples, separate the plasma and store plasma and red blood cell aliquots at -70°C. One plasma aliquot will be analysed in Keneba to measure homocysteine using the Cobas Integra 400 Plus analyser.
The hypothesis is that the novel micronutrient supplement will reduce plasma by at least 1 µmol/L compared to the control group after 12 weeks of daily supplementation. It will be more effective in reducing plasma homocysteine than existing UNIMMAP tablets.
This trial is powered to study to detect a decrease of 1 µmol/L homocysteine with 80% power and 95% confidence. The trial statistician will use a linear regression model to determine the mean difference between intervention and control homocysteine at 12 weeks adjusted for baseline homocysteine, week 12 age and week 12 body mass index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3-arm randomized controlled trial, unblinded, with 125 women per arm.
| Arm | Type | Receives |
|---|---|---|
| oral nutritional supplementation | Experimental | Dietary Supplement: novel micronutrientDaily novel micronutrient supplement: 800 μg folic acid, 5.2 μg cyanocobalamin (B12), 2.8 mg Riboflavin-5'- phosphate (B2), 4g trimethylglycine (betaine) in drink powder form. The drink will be dissolved in 200ml of water and taken daily for 12 weeks |
| oral nutritional supplementation, UNIMMAP | Active comparator | Dietary Supplement: existing micronutrient supplement, UNIMMAPThe United Nations Multiple Micronutrient Preparation (UNIMMAP) supplement is a capsule containing 15 micronutrients (vitamins A, D, E, B1, B2, B6, B12, C, Niacin, Folic Acid, Fe, Zn, Cu, I, Se) at the Recommended Daily Allowance level. UNIMMAP will be provided in capsule form and taken daily with water for 12 weeks. |
| control | No intervention | –no treatment will be given to this group observation only (no placebo) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pre-menopausal women aged 18-45 years
- Healthy with no current illness and no chronic health problems, asked verbally by field worker
Key exclusion criteria (3 listed)
- Known history of chronic illness (particularly cardiovascular disease, renal disease, thyroid disease, cancer)
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 |
|---|---|---|
| novel micronutrientThe supplements will be supplied to participants on a daily basis. The novel micronutrient supplement will be provided in powder form with instructions to dissolve one sachet in 250ml of clean water | Dietary supplement | oral nutritional supplementation |
| existing micronutrient supplement, UNIMMAPUNIMMAP will be provided in tablet form and given one daily | Dietary supplement | oral nutritional supplementation, UNIMMAP |
Primary outcome
Difference in plasma homocysteine concentration between the drink powder and control arms at end-lineplasma Hcy vs control
Time frame: after 12 weeks
To compare the effect of a novel micronutrient supplement taken daily for 12 weeks in the dry season on lowering plasma homocysteine versus the control group supplement taken daily for 12 weeks in the dry season on lowering plasma homocysteine (Hcy) versus the control group
3 secondary outcomes
Difference in plasma homocysteine concentration between the drink powder and UNIMMAP arms at end-line
Time frame: after 12 weeks
Difference in plasma homocysteine concentration between the the drink powder and UNIMMAP arms at mid-line
Time frame: after 6 weeks
Difference in blood pressure (systolic and diastolic) and pulse between the drink powder and control arms at end-line
Time frame: after 12 weeks
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 22 Jan 2019.
- Derived from this study: PubMed 31408467James PT, Jawla O, Mohammed NI, Ceesay K, Akemokwe FM, Sonko B, Sise EA, Prentice AM, Silver MJ. A novel nutritional supplement to reduce plasma homocysteine in nonpregnant women: A randomised controlled trial in The Gambia. PLoS Med. 2019 Aug 13;16(8):e1002870. doi: 10.1371/journal.pmed.1002870. eCollection 2019 Aug.
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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.
Andrew Prentice, PhD principal investigator
Medical Research Council Unit, The Gambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing novel micronutrient and existing micronutrient supplement, UNIMMAP in people with Micronutrient Deficiencies and Hyperhomocysteinemia, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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 6 inclusion and 3 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 22 Jan 2019. 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 The Gambia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Difference in plasma homocysteine concentration between the drink powder and control arms at end-lineplasma Hcy vs control (time frame: after 12 weeks). 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 NCT03431597, which also lists 1 linked publication.
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 22 Jan 2019.