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Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms
Plain-language guide to NCT03069313: not phased interventional trial of Cyanocobalamin (Vitamin B12), 41 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03069313
- Phase
- not phased
- Status
- completed
- Start
- 2015-10-19
- Completion (planned or actual)
- 2016-10-27
- Participants
- 41 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Relief of Joint Pain
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Cyanocobalamin (Vitamin B12).
Vitamin B12, whether as injection or oral forms, has been used as a naturopathic product to provide relief for joint pain caused by arthritis.
It had 1 arm (groups): Arm I (experimental).
Oral Vitamin B12.
The registry classes the interventions as dietary supplement.
More on the Plan
To explore the impact of treatment on serum inflammatory cytokine levels (C Reactive Protein) with 12 weeks of treatment between baseline and 12 weeks.
Who Took Part
Enrollment: 41 actual participants took part.
It was open to women only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Sign informed consent and Pain level \> 4 in the BPI scale,.
The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: \<18 yrs; stage iv; BPI Score \<4.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2015-10-19 with completion listed for 2016-10-27.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Percentage Change in Average Joint Pain in Women With Aromatase Inhibitor-associated Musculoskeletal Symptoms (AIMSS) Compared to Baseline as Measured by the Brief Pain Inventory Short Form (BPI-SF) (time frame: Baseline and 90 days (+/- 10 days)).
It also tracked 3 secondary outcomes, for example Percentage Change in Worst Pain at the End of Treatment , Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES) and Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA).
What This Means in Plain Language
Put simply, this is a not phased trial of Cyanocobalamin (Vitamin B12) in 41 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.
Our Notes on the Compound
Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.