The aim Project
Vitamin D and Fibroids Trial
There is evidence that Vitamin D plays a role in inhibiting the development and growth of uterine leiomyomas (Reference) including work by Dr Othman, the AWARrD Principal Investigator (Reference). In fact, in vitro laboratory evidence has demonstrated that vitamin D (VitD) inhibits cell proliferation as well as signaling pathways involving Wnt/β-catenin and transforming growth factor-β (TGFβ). Furthermore, in an xenograft animal model, Vitamin D treatment was associated with a reduction in measured leiomyoma volume (Reference). Given the disproportionate burden of leiomyomas borne by African women, and the potentially simple and inexpensive potential for Vitamin D therapy, many, including Professor Al-Hendy, have called for clinical trials evaluating the role of Vitamin D in management of fibroids. Indeed, Dr Al-Hendy and collaborators have performed and published extensively on the relationship between Vitamin D and leiomyoma growth and development (References).
Consequently, aim (Project 1) will include a double blind randomized clinical trial on women who are vitamin D deficient with symptomatic, MRI-confirmed-uterine fibroids. Women will be randomized to receive standard care or a regimen of high dose oral replenishment vitamin D3 for 6 months, followed by a maintenance dose for 6 months. Those in the control arm will receive the Institute of Medicine recommended average dose of vitamin D3 for one year. While the primary outcome will be MRI-measured change in total volume of uterine fibroids (UFs) we will assess the effect of the two treatments on quality of life.
If the Vitamin D trial demonstrates clear improvements in outcomes - including reductions in leiomyoma volume and improvements in quality of life, there will exist a viable intervention that may help women with fibroids throughout Africa and the world. In addition, such an outcome would create hypothesis that Vitamin D may have a role in the prevention of uterine leiomyomas.
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