Vitamin B12 DeficiencyPhase 4EASYVITNCT07029698
A Study to See if a Combination of Vitamins That is Injected Into a Muscle is as Good and Safe as a Vitamin That is Taken by Mouth
A Phase 4 study testing Vitamin B12, Vitamin B6, Folic acid and Vitamin B12 (Cyanocobalamin) in people with Vitamin B12 Deficiency, run by Medice Arzneimittel Pütter GmbH & Co KG at 2 sites in Ukraine.
Trial summary
Primary efficacy objective: To investigate the effects of a parenterally vitamin B12 combination treatment versus an oral vitamin B12 mono therapy on the vitamin B12 status in female and male patients as determined by the change from baseline in serum vitamin B12 concentration after 4 weeks (28 days) of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin B12 Deficiency
- What is being tested?
- Vitamin B12, Vitamin B6, Folic acid and Vitamin B12 (Cyanocobalamin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUkraine
- Study dates
- 16 Apr 2025to 7 Oct 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent to participate in the study (according to Order of the Ministry of Health of Ukraine No. 690 (with amendments)).
- Female and male patients aged ≥18.
- Vitamin B12 deficiency, defined as serum vitamin B12 < 350 pmol/L.
- Female patients of childbearing potential (WOCBP) must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc., with the exception of oral contraceptives), from the time of screening and for the duration of the study, through study completion and for 1 month following study completion. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Female patients who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. All female patients of childbearing potential must have negative pregnancy test results at screening. An additional pregnancy test will be performed on Days 0, 28, 56.
- Able to communicate well with the investigator and able to understand and comply with the requirements of the study.
- Patients are otherwise in relatively good health as determined by past medical history, physical examination, vital signs, and laboratory tests at screening (V -1).
Who cannot join
- Active or recent vitamin B12, folic acid, B6 intake (the subject must not receive vitamin B12, folic acid, B6 drugs or food supplements for at least 6 months).
- Participation in a previous clinical study with vitamin B12 within the 6 months prior to screening.
- Any contraindication to one of the study drugs.
- Pregnant or nursing (lactating) women.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- Subjects with anemia (hemoglobin < 10 mg/dL) or significant neurological symptoms due to vitamin B12 deficiency.
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- Any diseases that prevent intrinsic-factor independent passive diffusion in the small intestine (e.g. ileum resection)
- Current drug addiction and/or alcohol abuse as evidenced by patient history and/or as determined by the investigator at V-1.
- Cognitive or behavioural abnormalities that could impair the capacity to give informed consent or carry out protocol-specified procedures.
- Inability to take oral medication.
- Inability or unwillingness to comply with the study protocol.
- Previous (last 6 months) or current participation in another clinical study.
- Other medical, neuropsychiatric, or social conditions that, in the opinion of the investigator, are likely to adversely affect the risk-benefit of study participation, interfere with study compliance, or confound the study results.
- Subjects who are in a dependent relationship with the Investigator or the Sponsor.
- Subjects unwilling to give written informed consent to saving and/or propagation of anonymised medical data
Trial locations and contacts
2 sites in 1 country.
Ukraine2 sites
State institution "V. Danilevsky Institute for Endocrine Pathology Problems of the NAMS of Ukraine"
Kharkiv, 61002
Private Enterprise Private Manufacturing Company "Acinus"
Kropyvnytskyi, 25006
About this study
Official title: Efficacy and Safety of a Parenterally Administered Fixed Vitamin Combination (Vitamin B6, B12 and Folic Acid) On Vitamin B12 Status and Methylation Capacity in Cobalamin Deficiency Compared to Oral Vitamin B12 Supplementation
Primary efficacy objective:
To investigate the effects of a parenterally vitamin B12 combination treatment versus an oral vitamin B12 mono therapy on the vitamin B12 status in female and male patients as determined by the change from baseline in serum vitamin B12 concentration after 4 weeks (28 days) of treatment.
Read more
Secondary efficacy objectives:
To evaluate the effects of a parenterally vitamin B12 combination versus an oral vitamin B12 mono therapy after 4 weeks of treatment on:
- Serum holotranscobalamin
- Serum homocysteine
- Serum methylmalonic acid
- Combined vitamin B12 markers (cB12)
- Serum folic acid
- Serum vitamin B6
- Serum S-adenosylmethione (SAM)
- Serum S-adenosylhomocysteine (SAH)
- SAM/SAH ratio
- WHO-5 Well-Being Index
- Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
- Visual analogue scale (VAS) EQ-5D.
Safety objectives:
To evaluate the safety and tolerability of oral vitamin B12 mono therapy versus intramuscular vitamin B12 combination.
- Conditions
- Vitamin B12 Deficiency
- Being tested
- Vitamin B12, Vitamin B6, Folic acid, Vitamin B12 (Cyanocobalamin)
- Keywords
- Vitamin B12 deficiency, Vitamin B12 status, methylation capacity, holotranscobalamin, homocysteine, methylmalonic acid, folic acid, vitamin B6, S-adenosylmethione, S-adenosylhomocysteine
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12, Vitamin B6, Folic acidDrug
Also called Medivitan® iM
A solution for intramuscular injection of fixed vitamin combination (5 mg vitamin B6, 1 mg B12 and 1,05 mg folic acid )
Vitamin B12 (Cyanocobalamin)Drug
Also called B12 Ankermann®
oral tablets of 1mg Vitamin B12
| Study group | Role | What they receive |
|---|---|---|
| Vitamin injection | Experimental | 1 injection twice weekly at the clinical site. Totally 8 injections through 4 week treatment period Receives: Drug: Vitamin B12, Vitamin B6, Folic acid |
| Vitamin B12 tablet | Active comparator | 1 oral tablet once daily in the morning. Totally 28 tablets at approximately the same time each day through 4 week treatment period Receives: Drug: Vitamin B12 (Cyanocobalamin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin B12
Effects of treatment on serum vitamin B12
Measured: Change from baseline at day 28
Secondary outcomes (10)
Holotranscobalamin
Effects of treatment on serum holotranscobalamin
Measured: Change from baseline at day 28 and at follow up at day 56
Homocystein
Effects of treatment on serum homocystein
Measured: Change from baseline at day 28 and at follow up at day 56
Methylmalonic acid
Effects of treatment on serum methylmalonic acid
Measured: Change from baseline at day 28 and at follow up at day 56
Combined vitamin B12 marker (cB12)
Effects of treatment on cB12. Combined vitamin B12 markers (cB12) will be statistically calculated using the levels of Serum holotranscobalamin, Serum homocysteine, Serum methylmalonic acid. cB12 (cB12=log10[(holoTC x B12)/(MMA x Hcy)]-(age factor).
Measured: Change from baseline at day 28 and at follow up at day 56
Serum S-adenosylmethione (SAM)
Effects of treatment on serum S-adenosylmethione (SAM)
Measured: Change from baseline at day 28 and at follow up at day 56
Serum S-adenosylhomocysteine (SAH)
Effects of treatment on serum S-adenosylhomocysteine (SAH)
Measured: Change from baseline at day 28 and at follow up at day 56
SAM/SAH ratio
The change of the ratio will be assessed statistically using the levels of Serum S-adenosylmethione (SAM) and Serum S-adenosylhomocysteine (SAH)
Measured: Change from baseline at day 28 and at follow up at day 56
Quality of life assessed with SF-36
Effects of treatment on SF-36 questionnaire (from 0 to 100 points in each of the eight subscales, where the higher score means the higher quality of patient's life in each domain)
Measured: Change from baseline at day 28 and at follow up at day 56
Quality of life assessed with WHO-5 questionnaire
Effects of treatment on WHO-5 questionnaire (from 0 to 25, where the higher score means the higher quality of patient's life)
Measured: Change from baseline at day 28 and at follow up at day 56
Quality of life assessed with VAS EQ-5D
Effects of treatment on visual analogue scale EQ-5D (from 0 "the worst possible quality of life" to 10 "the best possible quality of life")
Measured: From baseline to day 28 and at follow up at day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start16 Apr 2025
- Primary completion7 Oct 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vitamin B12 DeficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase IV, randomized, open label, controlled, multicenter, two parallel-group study in female and male patients with vitamin B12 deficiency, to assess the efficacy and safety of two different application routes of vitamin B12.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029698
- Sponsor's protocol ID
- 6630-4200-42
- Acronym
- EASYVIT
- Status last verified
- Sep 2026
- First submitted
- 1 May 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962Naurath HJ, Riezler R, Putter S, Ubbink JB. Does a single vitamin B-supplementation induce functional vitamin B-deficiency? Clin Chem Lab Med. 2001 Aug;39(8):768-71. doi: 10.1515/CCLM.2001.128.
PubMed 11592449Ubbink JB, van der Merwe A, Delport R, Allen RH, Stabler SP, Riezler R, Vermaak WJ. The effect of a subnormal vitamin B-6 status on homocysteine metabolism. J Clin Invest. 1996 Jul 1;98(1):177-84. doi: 10.1172/JCI118763.
PubMed 8690790Fedosov SN, Brito A, Miller JW, Green R, Allen LH. Combined indicator of vitamin B12 status: modification for missing biomarkers and folate status and recommendations for revised cut-points. Clin Chem Lab Med. 2015 Jul;53(8):1215-25. doi: 10.1515/cclm-2014-0818.
PubMed 25720072Metaxas C, Mathis D, Jeger C, Hersberger KE, Arnet I, Walter P. Early biomarker response and patient preferences to oral and intramuscular vitamin B12 substitution in primary care: a randomised parallel-group trial. Swiss Med Wkly. 2017 Apr 7;147:w14421. doi: 10.4414/smw.2017.14421. eCollection 2017.
PubMed 28421567Smith AD, Warren MJ, Refsum H. Vitamin B12. Adv Food Nutr Res. 2018;83:215-279. doi: 10.1016/bs.afnr.2017.11.005. Epub 2018 Feb 2.
PubMed 29477223Conzade R, Koenig W, Heier M, Schneider A, Grill E, Peters A, Thorand B. Prevalence and Predictors of Subclinical Micronutrient Deficiency in German Older Adults: Results from the Population-Based KORA-Age Study. Nutrients. 2017 Nov 23;9(12):1276. doi: 10.3390/nu9121276.
PubMed 291687371. Vitamin B12 (Cobalamine). Referenzwerte für die Nährstoffzufuhr. Bonn, Deutsche Gesellschaft für Ernährung, Österreichische Gesellschaft für Ernährung, Schweizerische Gesellschaft für Ernährung (Hrsg.). 4. Aktualisierte Ausgabe 2018.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Parenterally Administered Fixed Vitamin Combination (Vitamin B6, B12 and Folic Acid) On Vitamin B12 Status and Methylation Capacity in Cobalamin Deficiency Compared to Oral Vitamin B12 Supplementation
- ClinicalTrials.gov ID
- NCT07029698
- Acronym / sponsor ID
- EASYVIT / 6630-4200-42
- Conditions
- Vitamin B12 Deficiency
- Keywords
- Vitamin B12 deficiency, Vitamin B12 status, methylation capacity, holotranscobalamin, homocysteine, methylmalonic acid, folic acid, vitamin B6
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 19 Jun 2025 (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.
Primary efficacy objective:
To investigate the effects of a parenterally vitamin B12 combination treatment versus an oral vitamin B12 mono therapy on the vitamin B12 status in female and male patients as determined by the change from baseline in serum vitamin B12 concentration after 4 weeks (28 days) of treatment.
Secondary efficacy objectives:
To evaluate the effects of a parenterally vitamin B12 combination versus an oral vitamin B12 mono therapy after 4 weeks of treatment on:
- Serum holotranscobalamin
- Serum homocysteine
- Serum methylmalonic acid
- Combined vitamin B12 markers (cB12)
- Serum folic acid
- Serum vitamin B6
- Serum S-adenosylmethione (SAM)
- Serum S-adenosylhomocysteine (SAH)
- SAM/SAH ratio
- WHO-5 Well-Being Index
- Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
- Visual analogue scale (VAS) EQ-5D.
Safety objectives:
To evaluate the safety and tolerability of oral vitamin B12 mono therapy versus intramuscular vitamin B12 combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Phase IV, randomized, open label, controlled, multicenter, two parallel-group study in female and male patients with vitamin B12 deficiency, to assess the efficacy and safety of two different application routes of vitamin B12.
| Arm | Type | Receives |
|---|---|---|
| Vitamin injection | Experimental | Drug: Vitamin B12, Vitamin B6, Folic acid1 injection twice weekly at the clinical site. Totally 8 injections through 4 week treatment period |
| Vitamin B12 tablet | Active comparator | Drug: Vitamin B12 (Cyanocobalamin)1 oral tablet once daily in the morning. Totally 28 tablets at approximately the same time each day through 4 week treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of written informed consent to participate in the study (according to Order of the Ministry of Health of Ukraine No. 690 (with amendments)).
- Female and male patients aged ≥18.
- Vitamin B12 deficiency, defined as serum vitamin B12 < 350 pmol/L.
- Female patients of childbearing potential (WOCBP) must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc., with the exception of oral contraceptives), from the time of screening and for the duration of the study, through study completion and for 1 month following study completion. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Female patients who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. All female patients of childbearing potential must have negative pregnancy test results at screening. An additional pregnancy test will be performed on Days 0, 28, 56.
- Able to communicate well with the investigator and able to understand and comply with the requirements of the study.
Key exclusion criteria (15 listed)
- Active or recent vitamin B12, folic acid, B6 intake (the subject must not receive vitamin B12, folic acid, B6 drugs or food supplements for at least 6 months).
- Participation in a previous clinical study with vitamin B12 within the 6 months prior to screening.
- Any contraindication to one of the study drugs.
- Pregnant or nursing (lactating) women.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
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 |
|---|---|---|
| Vitamin B12, Vitamin B6, Folic acidAlso: Medivitan® iMA solution for intramuscular injection of fixed vitamin combination (5 mg vitamin B6, 1 mg B12 and 1,05 mg folic acid ) | Drug | Vitamin injection |
| Vitamin B12 (Cyanocobalamin)Also: B12 Ankermann®oral tablets of 1mg Vitamin B12 | Drug | Vitamin B12 tablet |
Primary outcome
Vitamin B12
Time frame: Change from baseline at day 28
Effects of treatment on serum vitamin B12
10 secondary outcomes
Holotranscobalamin
Time frame: Change from baseline at day 28 and at follow up at day 56
Homocystein
Time frame: Change from baseline at day 28 and at follow up at day 56
Methylmalonic acid
Time frame: Change from baseline at day 28 and at follow up at day 56
Combined vitamin B12 marker (cB12)
Time frame: Change from baseline at day 28 and at follow up at day 56
Serum S-adenosylmethione (SAM)
Time frame: Change from baseline at day 28 and at follow up at day 56
Serum S-adenosylhomocysteine (SAH)
Time frame: Change from baseline at day 28 and at follow up at day 56
SAM/SAH ratio
Time frame: Change from baseline at day 28 and at follow up at day 56
Quality of life assessed with SF-36
Time frame: Change from baseline at day 28 and at follow up at day 56
Quality of life assessed with WHO-5 questionnaire
Time frame: Change from baseline at day 28 and at follow up at day 56
Quality of life assessed with VAS EQ-5D
Time frame: From baseline to day 28 and at follow up at day 56
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 4 Sep 2026.
- Background: PubMed 25831962Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Background: PubMed 11592449Naurath HJ, Riezler R, Putter S, Ubbink JB. Does a single vitamin B-supplementation induce functional vitamin B-deficiency? Clin Chem Lab Med. 2001 Aug;39(8):768-71. doi: 10.1515/CCLM.2001.128.
- Background: PubMed 8690790Ubbink JB, van der Merwe A, Delport R, Allen RH, Stabler SP, Riezler R, Vermaak WJ. The effect of a subnormal vitamin B-6 status on homocysteine metabolism. J Clin Invest. 1996 Jul 1;98(1):177-84. doi: 10.1172/JCI118763.
- Background: PubMed 25720072Fedosov SN, Brito A, Miller JW, Green R, Allen LH. Combined indicator of vitamin B12 status: modification for missing biomarkers and folate status and recommendations for revised cut-points. Clin Chem Lab Med. 2015 Jul;53(8):1215-25. doi: 10.1515/cclm-2014-0818.
- Background: PubMed 28421567Metaxas C, Mathis D, Jeger C, Hersberger KE, Arnet I, Walter P. Early biomarker response and patient preferences to oral and intramuscular vitamin B12 substitution in primary care: a randomised parallel-group trial. Swiss Med Wkly. 2017 Apr 7;147:w14421. doi: 10.4414/smw.2017.14421. eCollection 2017.
- Background: PubMed 29477223Smith AD, Warren MJ, Refsum H. Vitamin B12. Adv Food Nutr Res. 2018;83:215-279. doi: 10.1016/bs.afnr.2017.11.005. Epub 2018 Feb 2.
- Background: PubMed 29168737Conzade R, Koenig W, Heier M, Schneider A, Grill E, Peters A, Thorand B. Prevalence and Predictors of Subclinical Micronutrient Deficiency in German Older Adults: Results from the Population-Based KORA-Age Study. Nutrients. 2017 Nov 23;9(12):1276. doi: 10.3390/nu9121276.
- Background1. Vitamin B12 (Cobalamine). Referenzwerte für die Nährstoffzufuhr. Bonn, Deutsche Gesellschaft für Ernährung, Österreichische Gesellschaft für Ernährung, Schweizerische Gesellschaft für Ernährung (Hrsg.). 4. Aktualisierte Ausgabe 2018.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin B12, Vitamin B6, Folic acid and Vitamin B12 (Cyanocobalamin) in people with Vitamin B12 Deficiency, run by Medice Arzneimittel Pütter GmbH & Co KG at 2 sites in Ukraine.
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 15 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ukraine. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Vitamin B12 (time frame: Change from baseline at day 28). 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 NCT07029698, which also lists 8 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 4 Sep 2026.