Directly Observed Vitamin D therapy is one of many ways to increase compliance – RCT

Created March 2017

A randomized controlled trial testing an adherence-optimized Vitamin D regimen to mitigate bone change in adolescents being treated for acute lymphoblastic leukemia

Leukemia & Lymphoma online: 20 Feb 2017, http://dx.doi.org/10.1080/10428194.2017.1289526

Etan Orgel, Nicole M. Mueske, Richard Sposto, Vicente Gilsanz, Tishya A. L. Wren, David R. Freyer,

* Yes, children and adults often fail to consistently take pills such as Vitamin D * “Directly observed therapy” described by this study insures compliance Other solutions, which are unique to vitamin D, include: * Initiate therapy with a loading dose, providing positive feedback (less pain) a week instead of many months. * Take only a few Vitamin D capsules per month from blister pack– easily see what has been taken during the month and take any remaining capsules by the end of the month * Home fortification of food or drink with water soluble vitamin D * examples include: jam, peanut butter, milk, juice, cereal, . . * Injection once every 3 months: Home injections should be pre-labeled, eg. Jan, March, June, Sept This study found that achieving their Vitamin D goal did not treat osteopenia. It is unlikely that their goal was 40 nanograms/mL, which has been found to be needed to treat osteopenia. The goal of the study was probably 20 nanograms or possibly only 12.5 nanograms. Publisher wants $54 for the PDF

Adolescents with acute lymphoblastic leukemia (ALL) develop osteopenia early in therapy, potentially exacerbated by high rates of concurrent Vitamin D deficiency. We conducted a randomized clinical trial testing a Vitamin D-based intervention to improve Vitamin D status and reduce bone density decline. Poor adherence to home supplementation necessitated a change to directly observed therapy (DOT) with intermittent, high-dose Vitamin D3 randomized versus standard of care (SOC).

Compared to SOC, DOT Vitamin D3 successfully increased trough Vitamin 25(OH)D levels (p = .026) with

  • no residual Vitamin D deficiency,

  • 100% adherence to DOT Vitamin D3, and

  • without associated toxicity.

However, neither Vitamin D status nor supplementation impacted bone density.

Thus, this adherence-optimized intervention is feasible and effective to correct Vitamin D deficiency in adolescents during ALL therapy.

Repletion of Vitamin D and calcium alone did not mitigate osteopenia, however, and new, comprehensive approaches are needed to address treatment-associated osteopenia during ALL therapy.

Tags: Fortification How, and when