Wednesday, December 19, 2012

RCT: Vitamin D levels and traumatic brain injury


RCT: Vitamin D levels and traumatic brain injury

A new randomized controlled trial from Iran suggests that vitamin D could play an important role in the treatment of traumatic brain injury.
The study, led by Professor Bahram Aminmansour and colleagues from Isfahan University of Medical Sciences, investigated whether vitamin D in conjunction with progesterone could improve recovery rates in patients with traumatic brain injury.
Currently, physicians have few drugs that are effectively neuro-protective after a traumatic brain injury. Progesterone has been identified as safe and effective, protecting the blood-brain barrier, and helping prevent cerebral edema, excessive inflammatory response, and necrosis. It also helps stimulate myelin formation, reduces free radicals, and helps prevent neuronal loss.
Recent studies have suggested that vitamin D deficiency may worsen traumatic brain injury and reduce the effects of current treatment. Like progesterone, activated vitamin D is a neurosteroid and has proven to be effective aiding recovery in animal models, perhaps by mechanisms similar to progesterone, which is also a steroid hormone.
The researchers enrolled patients admitted for traumatic brain injury, treating them in less than 8 hours of admission. They randomized 60 patients into three groups, with 20 patients in each of the following groups:
  1. Progesterone. These patients were injected with one mg/kg of progesterone intramuscularly every 12 hours for 5 days.
  2. Progesterone and vitamin D. These patients were injected with one mg/kg of progesterone intramuscularly every 12 hours for 5 days and also 200 IU/kg of vitamin D once-a-day for 5 days. For a 150 lb person, this would be 13,600 IU of vitamin D/day for five days.
  3. Placebo. These 20 patients were injected intramuscularly with placebo.
The researchers used the Glasgow Coma Scale to assess patients, which is a 15 point scale that monitors severity of coma via eye, verbal and motor responses; the higher the score, the better the consciousness. Prior to treatment, the three group had equivalent scores of around six.
Three months after intervention, patients in the progesterone + vitamin D group had the highest mean scale rating at 11.27, followed by progesterone alone at 10.25 and then placebo at 9.16 (p=.001).
Furthermore, after 3 months, 35% of patients in the progesterone + vitamin D group made “Good Recovery,” as assessed by the Glasgow Outcome Scale, while only 25% met this assessment in the progesterone group and only 15% in the placebo group (p=.03). Ten-percent died in the progesterone + vitamin D group, compared to 20% in the progesterone group and 40% in the placebo group (p=.03).
The authors note that the progesterone + vitamin D group showed the most favorable results likely because of a variety of complimentary mechanisms, including vitamin D’s beneficial role in the immune system, its anti-inflammatory action and reduction of TH1 cytokines. Furthermore, vitamin D prevents intracellular hypercalcemia (not promotes).
The researchers conclude:
“The use of combined progesterone and vitamin D is reasonable in that vitamin D in combination with progesterone improves repair mechanisms of the central nervous system considering their common pathways, and also compensates other mechanisms, which are not performed by progesterone. This reduces the . . . probable failure of a single treatment.”
Source:
Aminmansour B et al. Comparison of the administration of progesterone versus progesterone and vitamin D in improvement of outcomes in patients with traumatic brain injury: A randomized clinical trial with placebo group. Adv Biomed Res, 2012

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