Effect of Daily Vitamin D Supplementation on Serum Vitamin D Levels in Children with Epilepsy Receiving Sodium Valproate Monotherapy: A Randomized, Controlled Trial.
Study Goal
The researchers aimed to compare changes in serum calcium levels and other bone mineral metabolism markers between vitamin D supplemented and unsupplemented children with epilepsy on valproate monotherapy.
Results Summary
The study found a significant decrease in ionized calcium levels in the unsupplemented group compared to the supplemented group, alongside increases in serum phosphate and alkaline phosphatase levels, indicating vitamin D supplementation mitigated valproate-associated negative effects on calcium metabolism.
Population
Children aged 2-12 years with newly diagnosed epilepsy and vitamin D sufficient status, started on valproate monotherapy.
Effective Dosage
600 IU vitamin D daily
Duration
3 months
Interactions
Valproate monotherapy (negative impact on calcium metabolism mitigated by vitamin D supplementation)
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
daily oral 600 IU vitamin D supplementation | increase | vitamin D levels | children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy | 5.66 (1.81, 7.12) | increase seen | #1 |
- | decrease | vitamin D levels | children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy | -6.64 (-8.4, -2.65) | significant reduction | #2 |
- | increase | vitamin D insufficiency | children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy | 37.5% | developed | #3 |
- | increase | vitamin D deficiency | children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy | 12.5% | developed | #4 |
daily oral 600 IU vitamin D supplementation | increase | vitamin D insufficiency | children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy | 5% | developed | #5 |
- | decrease | ionized calcium | children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy | - | significant decrease | #6 |
- | increase | serum phosphate | children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy | - | increase | #7 |
- | increase | alkaline phosphatase level | children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy | - | increase | #8 |
Vitamin D supplementation | decrease | the valproate-associated decline in vitamin D levels | children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy | - | can reduce | #9 |
Vitamin D supplementation | decrease | the negative impact on other markers of bone mineral metabolism | children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy | - | can reduce | #10 |
OBJECTIVES: To compare the change in serum vitamin D levels and to compare the changes in serum levels of calcium, phosphate, alkaline phosphatase and parathyroid hormone in vitamin D supplemented and unsupplemented groups after 3 mo. METHODS: In this randomized, parallel group, nonblinded, controlled trial, 40 children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy, were randomized into the intervention group (n = 20), which was given daily oral 600 IU vitamin D supplementation, and the control group (n = 20), which was not given any supplementation. Changes in the biochemical parameters was measured in the two groups after 3 mo. RESULTS: There was a significant reduction in the median (IQR) vitamin D levels in the control group as compared to an increase seen in the intervention group [-6.64 (-8.4, -2.65) vs. 5.66 (1.81, 7.12); p < 0.001]. In the control group, 37.5% children developed vitamin D insufficiency and 12.5% developed deficiency whereas only 5% of the intervention group developed vitamin D insufficiency (p = 0.005). There was a significant decrease in ionized calcium (p = 0.02), increase in serum phosphate (p = 0.02), and alkaline phosphatase level (p = 0.003) in the unsupplemented group as compared to the supplemented group. CONCLUSION: Vitamin D supplementation can reduce the valproate-associated decline in vitamin D levels and the negative impact on other markers of bone mineral metabolism. TRIAL REGISTRATION: TCTR20200621002, 19.06.2020, retrospectively registered.