Vitamin D and nonalcoholic fatty liver disease in children: a randomized controlled clinical trial.
Study Goal
The researchers aimed to evaluate the role of vitamin D supplementation on hepatic fat content and NAFLD progression in children.
Results Summary
Vitamin D supplementation significantly improved hepatic steatosis and lobular inflammation, reduced AST, ALT, TG, LDL, FBG, FBI, and HOMA-IR, and increased vitamin D levels and HDL, but had no effect on hepatocyte ballooning or fibrosis.
Population
Children with biopsy-proven NAFLD (n=100).
Effective Dosage
2000 IU/day.
Duration
6 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
2000 IU/day vitamin D for 6 months | decrease | hepatic steatosis by liver biopsy | children with biopsy-proven NAFLD | - | significant improvement | #1 |
2000 IU/day vitamin D for 6 months | decrease | lobular inflammation by liver biopsy | children with biopsy-proven NAFLD | - | significant improvement | #2 |
2000 IU/day vitamin D for 6 months | no change | hepatocyte ballooning | children with biopsy-proven NAFLD | - | no significant effect | #3 |
2000 IU/day vitamin D for 6 months | no change | hepatic fibrosis | children with biopsy-proven NAFLD | - | no significant effect | #4 |
2000 IU/day vitamin D for 6 months | decrease | aspartate aminotransferase (AST) | children with biopsy-proven NAFLD | - | significant decrease | #5 |
2000 IU/day vitamin D for 6 months | decrease | alanine aminotransferase (ALT) | children with biopsy-proven NAFLD | - | significant decrease | #6 |
2000 IU/day vitamin D for 6 months | decrease | serum triglyceride (TG) | children with biopsy-proven NAFLD | - | significant decrease | #7 |
2000 IU/day vitamin D for 6 months | decrease | low-density lipoprotein (LDL) | children with biopsy-proven NAFLD | - | significant decrease | #8 |
2000 IU/day vitamin D for 6 months | decrease | fasting blood glucose (FBG) | children with biopsy-proven NAFLD | - | significant decrease | #9 |
2000 IU/day vitamin D for 6 months | decrease | fasting blood insulin level (FBI) | children with biopsy-proven NAFLD | - | significant decrease | #10 |
2000 IU/day vitamin D for 6 months | decrease | homeostasis model assessment of insulin resistance (HOMA-IR) | children with biopsy-proven NAFLD | - | significant decrease | #11 |
2000 IU/day vitamin D for 6 months | increase | vitamin D levels | children with biopsy-proven NAFLD | - | significant increase | #12 |
2000 IU/day vitamin D for 6 months | increase | high-density lipoprotein (HDL) | children with biopsy-proven NAFLD | - | significant increase | #13 |
Vitamin D supplementation | decrease | hepatic steatosis | children | - | significantly decreased | #14 |
Vitamin D supplementation | decrease | lobular inflammation | children | - | significantly decreased | #15 |
Vitamin D supplementation | decrease | grades of NAFLD | children | - | improved | #16 |
Vitamin D supplementation | no change | hepatocyte ballooning | children | - | no effect | #17 |
Vitamin D supplementation | no change | fibrosis | children | - | no effect | #18 |
Vitamin D is reported to have anti-inflammatory and insulin-sensitizing effects, yet vitamin D effects on hepatic fat content in children with nonalcoholic fatty liver disease (NAFLD) are not studied sufficiently. We aimed to evaluate the role of vitamin D supplementation on the hepatic fat content and NAFLD progression in children. This randomized controlled clinical trial was performed on 109 children with biopsy-proven NAFLD; only 100 patients completed the study. Patients were randomly assigned into two groups: the treatment group who received 2000 IU/day vitamin D for 6 months and the control group who received a placebo. Anthropometric measurements, vitamin D levels, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total cholesterol (TC), serum triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), fasting blood glucose (FBG), fasting blood insulin level (FBI), homeostasis model assessment of insulin resistance (HOMA-IR), and serum calcium level were measured at the beginning and the end of the study. Liver biopsy was taken before and at the end of the study for all included children. There was a significant improvement of the hepatic steatosis and lobular inflammation by liver biopsy in the treatment group after treatment. However, there was no significant effect on the hepatocyte ballooning or hepatic fibrosis. There were significant decrease of AST, ALT, TG, LDL, FBG, FBI, and HOMA-IR and significant increase of vitamin D levels and HDL in the treatment group compared to the placebo group (P < 0.05).Conclusion: Vitamin D supplementation was found to be beneficial in the treatment of NAFLD in children.Trial registration: www.pactr.org , PACTR201710002634203. What is Known: • Nonalcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver disease in pediatrics. • Several studies reported a negative association between low serum vitamin D level and grades of NAFLD. What is New: • Vitamin D supplementation has significantly decreased hepatic steatosis and lobular inflammation and improved the grades of NAFLD in children, confirmed by liver biopsy, but no effect on hepatocyte ballooning or fibrosis was observed. • Adjuvant vitamin D supplementation is recommended in children with NAFLD.