Vitamin D which dissolves in mouth for those having poor response due to poor guts, HSCT etc.- June 2023

Optimized Vitamin D Repletion in Refractory Patients Undergoing Stem Cell Transplant with Oral Thin Film Cholecalciferol

Blood Adv. 2023 Jun 7;bloodadvances.2023009855. doi: 10.1182/bloodadvances.2023009855
Allison L Bartlett Allison.bartlett at cchmc.org 1, Grace Zhang 2, Gregory Wallace 3, Stacie McLean 3, Kasiani C Myers 1, Ashley Teusink-Cross 3, Cynthia Taggart 4, Bhaumik Patel 5, Robert Davidson 5, Stella M Davies 1, Sonata Jodele 1
1Division of Bone Marrow Transplantation and Immune Deficiency, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
2University of Cincinnati College of Medicine,
3Department of Pharmacy, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH;
4Department of Nutrition Therapy, Cincinnati Children’s Hospital Medical Center,Cincinnati, OH;
5CURE Pharmaceutical, Oxnard, CA

Vitamin D deficiency is common in childhood, pervasive before and after bone marrow transplant, and associated with increased incidence of graft-versus-host disease (GVHD) and decreased survival in patients undergoing hematopoietic stem cell transplantation (HSCT). Numerous barriers impede replacement, including malabsorption secondary to gut GVHD, mucositis, inability to take capsules, kidney disease, liver disease, and infection; many patients remain refractory despite vitamin D therapy. We hypothesized that a different formulation of cholecalciferol, administered on the tongue as a readily dissolving oral thin film (OTF), would ease administration and facilitate therapeutic vitamin D levels (>35 ng/mL) in refractory patients. In this prospective pilot study, we evaluated 20 patients post-HSCT (range: day +21 - day +428 at enrollment) with serum vitamin D levels </=35 ng/mL. Cholecalciferol OTF strips (CURE Pharmaceutical) were administered for twelve weeks. Dosing was based on patient size and titrated according to individual pharmacokinetics. Wilcoxon matched-pairs signed rank test demonstrated marked improvement in all 20 formerly refractory patients, increasing from a median baseline vitamin D of 29.2 ng/mL to 58 ng/mL at end of study (p<0.0001). All patients demonstrated improvement in serum vitamin D level by week 4 on study, some of whom had been refractory for years prior. Median dose was 1 OTF strip (40,000 IU) per week. No toxicity was observed. This formulation proved to be safe, effective, efficient, and well-received. We are eager to explore other patient populations which might benefit from this promising development, and other therapeutics which might be optimized by this mode of delivery.
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Vitamin D Life - Gut-Friendly Vitamin D

Vitamin D Life – Topical Vitamin D category contains

Topical is one of the many ways of increasing the vitamin D in your body
Topical is 2X to 50X more expensive than oral form
Topical is great for those who not want to swallow pillls nor fortifiy their food/drink with Vitamin D
Topical is one of the many gut-friendly forms of vitamin D (good bioavailability for those with poor guts
Topical is especially good form to apply directly to skin problems:
    - i.e. Psoriasis  Warts  Burns  Acne  Eczema  Wounds  (lasts about a day)
    The skin, like most tissues of the body, can fully-activate Vitamin D locally - no liver nor kidney needed.
Provides perhaps 100X higher concentration of Vitamin D to that portion than if same dose were taken orally
There were > 700 topical Vitamin D products on Amazon Aug, 2019
     Creams. oils, patches, nanoemulsions, etc.
Suspect that topical Vitamin D is best absorbed where the skin gets Vitamin D naturally
- - - face and hands vs the back or the inside of arms
Nanoemulsions can also be applied topically under the tongue and inhaled

Vitamin D Life – Injection is another non-gut way of getting Vitamin D

• Vitamin D injections last longer (3 month vs 2 month) than loading doses
• Getting Vitamin D into your body shows the many ways of getting Vitamin D

• Injections are currently made by medical professionals into muscle
• Home injection of Vitamin D appears to be possible in the future
• Injections are useful for people who might forget to take their periodic supplement (children, elderly, etc) and those who cannot swallow or have poor digestion
• While Vitamin D2 is historically the common form, Vitamin D3 is far better
• Should check (if there is time) for possible allergic reaction to Vitamin D or lack of Magnesium for both for loading dose and injection
• Note 600,000 IU Vitamin D loading dose via capsules is 1/20th the cost($2.40) of an injection, and does not require a prescription
• 100,000 IU single dose of vitamin D - 2010 has the following
  
• Vitamin D injection lasts longer and has bigger response than weekly oral – Jan 2017 has the following
  
• Non-oral Vitamin D should be a better form for MS, food allergy, PTSD, etc. – many studies might include injection

Vitamin D Life - Response to Vitamin D - many studies

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