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Original Research (Original Article) 


Osama Safdar et al, 2020;4(3):612–619.

International Journal of Medicine in Developing Countries

L-Carnitine effect on bone disease in hemodialysis pediatric patients in KAU Hospital, Jeddah Saudi Arabia: an experimental non-randomized study

Osama Safdar1, Ghazal Jambi2*, Omar Asaad2, Lujain Hassan2, Lujain AlDahlawi2, Abdalrashid F. Halawani2, Mohammed Jamjoom2, Bahaa Shaikhoon2, Ahmad Azhar3, Zaher F. Zaher3, Shatha Albokhari3, Mohammed Shalaby1

Correspondence to: Ghazal Jambi

*Faculty of Medicine, King Abdulaziz University, Alsulimania, Jeddah, Saudi Arabia.

Email: ghazal.jambi [at] gmail.com

Full list of author information is available at the end of the article.

Received: 23 November 2019 | Accepted: 20 January 2020


ABSTRACT

Background:

Patients with end-stage renal failure resort to different forms of renal replacement therapy, including peritoneal dialysis, hemodialysis, and renal transplantation. Hemodialysis patients often have reduced L-carnitine levels predisposing them to different musculoskeletal myopathies. This study aims to evaluate the beneficial circumstances of administering L-carnitine to dialyzed patients regarding improvements in the values of Parathyroid hormone (PTH), Calcium (Ca), Hemoglobin (HB), and Vitamin D levels (Vit D).


Methodology:

This experimental study was conducted in a non-randomized manner among a sample size of seven pediatric patients under 18 years of age undergoing dialysis with low L-carnitine levels in King Abdul-Aziz University Hospital, throughout 6 to 10 months. L-carnitine was administered at a fixed dose of 50 mg/kg. Our focus was directed on the levels PTH, Ca2+, Hb, VitD, and PO4.


Results:

The mean of phosphate was not significant with p-value 0.499. The mean of PTH level before administering the drug was 134.26 and after administering the drug it was found 57.41. This decrease was statistically significant with p-value 0.028. The mean of Ca was not significant with p-value 0.735. The mean of HB is not significant with p-value 0.499. The mean of Vit D was not significant (p-value 0.237).


Conclusion:

The only significant statistical result was involving PTH. Decreasing the level of PTH had several advantages most importantly it led to reduction of bone resorption; therefore, maintaining bone density and decreasing the likelihood of developing degenerative bone diseases.


Keywords:

Pediatric, hemodialysis, L-carnitine.


Introduction

End-stage renal failure (ESRF) occurs after a continued loss of kidney function, as a result of kidney damage with the loss of 85%–90% of renal function [1]. The incidences among children and adolescents of 12.1 new patients per million are (57.6%) [2]. ESRF might be a consequence of acute kidney injury or can result as a complication of many chronic illnesses. It is manifested by a decreased renal function with a glomerular filtration rate less than 15 ml/minute and the inability to compensate with the dependence on dialysis or other renal replacement therapy to maintain proper renal function [3]. Bone diseases are due to major changes in calcium (Ca), phosphate, parathyroid hormone (PTH), and vitamin D levels due to ESRF, thus causing an increased level of PTH to compensate for Ca loss. Ca resorption will occur resulting in bone diseases [1]. Also, hemoglobin levels were observed as erythropoietin level might be affected [4]. L-carnitine is an amino acid naturally synthesized within human bodies related to β-oxidation [5]. There are many theories regarding its role as both a biomarker and treatment of musculoskeletal diseases. Although relatively rare primary myopathies can result occasionally due to fatty acid oxidation disorders [6]. A study was conducted at the Dokuz Eylul University, Faculty of Medicine, Department of Pediatric Nephrology to investigate different etiologies and management of rhabdomyolysis in children, the etiologies were multiple and included a carnitine palmitoyltransferase II deficiency [7]. “Hemodialysis is a proven method of removing waste products and extra fluid, which builds up in the blood when the kidneys are no longer able to function properly” [8]. Although dialysis is sometimes essential for the survival of patients, it comes with many adverse effects related to multiple perspectives of treatment, including the admission of heparin as an anticoagulant, the symptoms of withdrawals of high amounts of blood, infections related to the access points, first use anaphylactic reactions, furthermore a low L-carnitine serum concentration which is relevant to our study. Due to limited studies conducted on L-Carnitine effects in children with renal failure we conducted this study to assess the benefits of L-Carnitine in pediatric patients undergoing hemodialysis.


Subjects and Methods

This experimental study was conducted in a non-randomized manner among a sample size of seven pediatric patients under 18 years of age undergoing dialysis with low L-carnitine levels in King Abdul-Aziz University Hospital, throughout 6 to 10 months. The children undergoing hemodialysis with normal L-carnitine serum levels were excluded from this study. The study was reviewed, examined, and ethically approved by the ethics committee at King Abdulaziz University Hospital (KAUH) in Jeddah, by its chairman, Prof. Hasan Alzahrani, on October 16th, 2014 reference no. 272-14. Informed consent was taken from all the subjects. The purpose of this study is to gain a better understanding of the potential outcomes of L-carnitine use on pediatric patients undergoing dialysis. The data were obtained retrospectively by the collection of quantitative patient laboratory results through hospital-based records at KAUH. The results following L-carnitine administration were obtained prospectively through Bioscientia Institute for medical diagnostics GmbH lab at Ingelheim Germany. Routine blood sampling methods were used to obtain a serum volume of 3-5cc into a red top SST tube, Total L-carnitine measurements were obtained. Initially, blood was centrifuged through Eppendorf centrifuge machine cycling at 3,500/second for 5 minutes, equivalent to seven cycles. L-carnitine was administered at a fixed dose of 50 mg/kg; compliance was confirmed in every patient through random blood tests. Although demographic variables were wide our focus was directed on PTH, Ca2+, Hb, VitD, and PO4. The statistical analysis was achieved using the Statistical Package for Social Sciences version 24 to analyze the data. Many statistical measures and tests have been employed in this study, such as descriptive statistics, One-Sample Kolmogorov–Smirnov Test to test the normality of the data, and the Wilcoxon Signed Ranks Test. p-value < 0.05 was considered as significant.


Results

The study sample consists of seven patients, who were initially—before taking any drug—examined by conducting laboratory tests for each of phosphate, PTH, Ca, Hb, and Vitamin D. For phosphate, the mean was 2.13, standard deviation (STD) (0.53), and range (1.54). For PTH, the mean was 134.26, STD (148.25), and range (431.4). For Ca, the mean was 2.19, STD (0.16), and range (0.51). For HB, the mean was 10.62, STD (1.55), and range (4.38), and for Vitamin D, the mean was 84.64, STD (39.5), and range (105.95). Table 1 shows all the descriptive tests conducted before taking any drug. All variables (laboratory tests before taking any drug) were checked for data errors or unusual values. The following Figures show the boxplots used to check each of the outcome measures: phosphate, PTH, Ca, HB, and Vitamin D. From these boxplots, all measures appear normally distributed. The outliers indicated (by circles/star and identifier number) were checked and were found not to be data errors and all were considered normal and possible values so were left as appeared in the data. The seven patients under the study were administered the drug L carnitine ranging through a period of 6–10 months, and then—after taking the drug—assessed through the same laboratory tests for each of phosphate, PTH, Ca, HB, and Vitamin D. For phosphate, the mean was 1.94, STD (0.58), and range (1.69). For PTH, the mean was 57.41, STD (44.82), and range (125.4). For Ca, the mean was 2.16, STD (0.23), and range (0.74). For HB, the mean was 10.91, STD (1.28), and range (3.26), and for Vitamin D, the mean was 67.89, STD (16.89), and range (48.58). Table 2 shows all the descriptive statistical tests conducted after taking the drug. To support the previous boxplots conducted, Table 3 shows the One-Sample Kolmogorov–Smirnov test for normality. For the outcome measures: phosphate, PTH, Ca, HB, and Vitamin D, the test values are not statistically significant (i.e., p > 0.05). Therefore, the phosphate, PTH, Ca, HB, and Vitamin D variables before taking any drug can be considered normally distributed. But, since the sample size is very small (only seven patients), we prefer using the non-parametric tests [1]. Table 4 and Figure 1 show that the mean of phosphate level before taking the drug is (2.13) and after taking the drug is (1.94), which means that taking L carnitine decreased the level of phosphate. But, this difference is not statistically significant since (p-value = 0.499) which is greater than (0.05). Table 5 and Figure 2 show that the mean of PTH level before administering the drug is (134.26) and after receiving the drug is (57.41), therefore taking L carnitine decreased the level of PTH. This decrease is statistically significant between the results of the PTH level before administering the drug and after receiving the drug since (p-value = 0.028) which is less than (0.05). Therefore, we conclude that providing the drug has remarkable effects on decreasing the level of PTH. Table 6 and Figure 3 show that the mean of Ca level before administering the drug is (2.19) and after administering the drug is (2.16). But, this is not of statistical significance since results of Ca levels before administering the drug and after receiving it had a (p-value = 0.735) which is greater than (0.05). Table 7 and Figure 4 show that the mean of HB level before introducing the drug is (10.62) and after introducing the drug is (10.91), which means that taking L carnitine increased the level of HB. But, the results were of no significance since (p-value = 0.499) which is greater than (0.05). Table 8 and Figure 5 show that the mean of Vitamin D level before receiving the drug is (84.64) and after receiving the drug is (67.89). We notice that there is a decrease in Vitamin D level after taking the drug, but this is not statistically significant since (p-value = 0.237) which is greater than (0.05). To conclude, the only significant statistical result was involving PTH. Decreasing the level of PTH has several advantages most importantly the reduction of bone resorption by osteoclasts, therefore maintaining bone density, and lessening the likelihood of osteoporosis, Osteomalacia, and other degenerative bone diseases.

Table 1. Descriptive statistics for each of Phosphate, PTH Calcium, HB, Vit D as pre-test.

Phosphate
(mmol/L) Pre
PTH
(Pmol/L) Pre
Calcium
(inmol/L)
Pre
HB (g/clL)
Pre
Vit D
(nmol/L) Pre
N 7 7 7 7 7
Mean ± Std. 134.26 ± 84.64 ±
2.13 ± 0.53 2.19 ± 0.16 10.62 ± 1.55
Deviation 148.25 39.50
Range 1.54 431.40 0.51 4.38 105.95
Minimum- 13.18– 28.75 –
1.33 – 2.87 1.96 – 2.47 8.23 – 12.60
maximum 444.58 134.70

Table 2. Descriptive statistics for each of Phosphate, PTH Calcium, HB, Vit D as pre-test.

Phosphate
(mmol/L)
Post
PTH
(Pmol/L) Post
Calcium
(mmol/L)
Post
HB (g/dL)
Pre
Vit D
(nmol/L)
Post
N 7 7 7 7 7
Mean±Std.
Deviation
1.94 ± 0.58 57.41 ± 44.82 2.16 ± 0.23 10.91 ± 1.28 67.89 ± 16.89
Range 1.69 125.40 0.74 3.26 48.58
Minimum-maximum 1.20 – 2.89 15.95 – 141.35 1.71 – 2.45 9.30 – 12.56 45.59 – 94.17

Table 3. One-Sample Kolmogorov-Smirnov Test for each of Phosphate, PTH Calcium, HB and Vitamin D.

Phosphate
(mmol/L)
Pre
PTH
(Pmol/L) Pre
Calcium
(mmol/L)
Pre
HB (g/dL)
Pre
Vit D
(nmol/L) Pre
Test Statistic 0.134 0.229 0.183 0.226 0.1 75
Asymp. Sig. (2tailed) 0.200 0.221 0.200 0.200 0.200

Table 4. Results of Wilcoxon Signed Ranks Test for Phosphate (post — pre).

Post - Pre
Test value (Z) -0.676b
p-value 0.499

a. Wilcoxon Signed Ranks Test

b. Based on positive ranks.

Figure 1. Comparison between levels of Phosphate (mmol/L) pre and post.

Table 5. Results of Wilcoxon Signed Ranks Test for PTH (post — pre).

PTH Post - PTH Pre
Test value (Z) -2.197b
p-value .028

a. Wilcoxon Signed Ranks Test

b. Based on positive ranks.

Figure 2. Comparison between levels of PTH (Pmol/L) pre and post.

Table 6. Results of Wilcoxon Signed Ranks Test for Calcium (post — pre).

Calcium Post - Calcium
Pre
Z -0.338b
Asymp. Sig. (2-tailed) 0.735

a. Wilcoxon Signed Ranks Test

b. Based on positive ranks.

Figure 3. Comparison between levels of Calcium (mmol/L) pre and post.


Discussion

In our study, we aimed to gain a better understanding of the effect of L-carnitine supplementation on anemia and bone diseases among pediatric patients undergoing hemodialysis. Our results indicated an increase in the mean hemoglobin level upon administration of L-carnitine. However, this increase was not statistically significant (p = 0.499). Also, we found that parathyroid hormone was the only parameter that was significantly decreased upon administrations of L-carnitine (p = 0.028), in comparison to the other parameters we measured to assess the status of bone diseases in hemodialytic patients, such as Ca, phosphorus, and vitamin D. The effect of L-carnitine supplementation in the management of anemic patients on hemodialysis was discussed in several studies and controversial results have been reported. One of the major studies that discussed these parameters was the meta-analysis performed by Chen et al. [9] which analyzed 31 studies with an overall 1,255 enrolled patients. The authors reported no significant effect of L-carnitine on hemoglobin levels by analyzing 14 trials with 693 patients. Similarly, there was no significant change in the level of hematocrit in nine trials with 406 patients, or the required dose of erythropoietin in eight trials with 319 patients. However, it should be noticed that the previous meta-analysis performed by the same authors revealed favorable effects of L-carnitine on hemoglobin level and the required dose of erythropoietin. The current negative findings of hemoglobin level were greatly affected by Bras et al’s [10] study which recruited 183 patients and contributed with nearly 24% of the overall negative findings reported in this meta-analysis. The authors reported that without the findings in this study, L-carnitine supplementation would have significantly increased the level of hemoglobin (p = 0.04). Similarly, the negative results of l-carnitine on the required doses of erythropoietin were very much affected by the results of two studies performed by Chazot et al. [11] and Vaux et al. [12] in comparison with the other studies included in the meta-analysis. On the other hand, Kitamura et al. [13] showed that L-carnitine prolongs the life span of RBCs and increases the number of erythroid colony formation in the cell cultures of mouse bone morrows [13]. Another study by Naini et al. [14] reported a significant decrease in the required dosage of erythropoietin upon administration of l-carnitine. In spite of the controversial results, our findings came consistent with the meta-analysis performed by Chen et al. [9] and reported a non-significant effect of l-carnitine on hemoglobin level in anemic patients on hemodialysis. However, the number of patients enrolled in most of these studies, including ours, was not enough and the sample sizes were small. This could affect the results and requires further investigations on larger study groups to provide more solid evidence [9,14]. The chronic deterioration of renal functions in patients with End-Stage Renal Diseases significantly effects on the calcium phosphate homeostasis and develop secondary hyperparathyroidism. This condition is mainly derived by the low level of calcitriol followed by low serum Ca level in addition to phosphate retention that follows the deteriorating ability of the kidney to handle the serum phosphate [15]. The previous consequences lead to hyperplasia of the parathyroid gland and production of an excessive amount of parathyroid hormone which, in turn, increases bone resorption and triggers dialysis-related bone disorders [16]. Cibulka et al. [17] hypothesized that long administration of l-carnitine can lead to improving the intracellular metabolic interactions and increase the level of phosphate consumption in the production of high-energy Adenosine Triphosphate molecules, thus decreasing the level of serum phosphate and subsequently decreasing the condition of bone disorder. They reported favorable changes in the level of phosphorus, parathyroid, and Ca among the supplemented groups. However, these changes were not statistically significant [17]. Ahmad et al. [18] managed to report a significant decrease in the level of phosphorus upon administration of l-carnitine supplementation for 6 months in hemodialytic patients. However, this study was performed on patients with relatively more serious hyperphosphatemia than the patients enrolled in the previous study by Cibulka et al. [17]. Our findings indicated a significant decrease in the level of parathyroid hormone upon administration of L-carnitine supplementation but we could not find any significant change in the level of other parameters such as phosphorus, Ca and vitamin D. A possible explanation for this is that we conducted our study on seven patients only, while Ahmed et al. [18] enrolled 82 patients and Cibulka et al. [17] enrolled 83 patients. From the previous findings, we reported a significant decrease in the level of parathyroid hormone after administration of L-carnitine in hemodialytic patients with bone disorders. However, we could not find any significant correlation with the other parameters of bone disease, such as Ca, phosphorus, and vitamin D, or the parameter of anemia like hemoglobin concentration. The major limitation of this study is the study sample and the non-randomized methodsof randomization that we followed. We could conduct the study on a larger number of patients. Hence, further investigations are recommended to obtain more reliable results as most of the literature reported controversial findings.

Table 7. Results of Wilcoxon Signed Ranks Test for HB (post — pre).

HB Post - HB Pre
Z -0.676c
Asymp. Sig. (2-tailed) 0.499

a. Wilcoxon Signed Ranks Test

b. Based on negative ranks.

Figure 4. Comparison between levels of HB (g/dL) pre and post.

Table 8. Results of Wilcoxon Signed Ranks Test for Vitamin D (post — pre).

Vit D Post - Vit D Pre
Z -1.183b
Asymp. Sig. (2-tailed) 0.237

a. Wilcoxon Signed Ranks Test

b. Based on positive ranks.

Figure 5. Comparison between levels of Vitamin D (nmol/L) pre and post.


Conclusion

The only significant statistical result was found involving PTH. Decreasing the level of PTH had several advantages most importantly it led to the reduction of bone resorption, therefore maintaining bone density and decreasing the likelihood of developing degenerative bone diseases.


List of Abbreviations

Ca Calcium
ESRF End-stage renal failure
Hb Hemoglobin
PTH Parathyroid hormone
Vit D Vitamin D levels
STD Standard deviation

Conflict of interest

The authors declare that there is no conflict of interest regarding the publication of this article.


Funding

None.


Consent for publication

Informed consent was obtained from all the participants.


Ethical approval

The study was approved by the ethics committee at KAUH in Jeddah, on October 16th, 2014 reference no. 272-14.


Author details

Osama Safdar1, Ghazal Jambi2, Omar Asaad2, Lujain Hassan2, Lujain AlDahlawi2, Abdalrashid F. Halawani2, Mohammed Jamjoom2, Bahaa Shaikhoon2, Ahmad Azhar3, Zaher F. Zaher3, Shatha Albokhari3, Mohammed Shalaby1

  1. Pediatric Nephrology Center of Excellence, Faculty of Medicine, King Abdulaziz University, Alsulimania, Jeddah, Saudi Arabia
  2. Faculty of Medicine, King Abdulaziz University, Alsulimania, Jeddah, Saudi Arabia
  3. Pediatric Department, Faculty of Medicine, King Abdulaziz University, Alsulimania, Jeddah, Saudi Arabia

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How to Cite this Article
Pubmed Style

Safdar O, Jambi G, Asaad O, Hassan L, AlDahlawi L, Halawani AF, Jamjoom M, Shaikhoon B, Azhar A, Zaher ZF, Albokhari S, Shalaby M. L-Carnitine effect on bone disease in hemodialysis pediatric patients in KAU Hospital, Jeddah Saudi Arabia: an experimental non-randomized study. IJMDC. 2020; 4(3): 612-619. doi:10.24911/IJMDC.51-1574511938


Web Style

Safdar O, Jambi G, Asaad O, Hassan L, AlDahlawi L, Halawani AF, Jamjoom M, Shaikhoon B, Azhar A, Zaher ZF, Albokhari S, Shalaby M. L-Carnitine effect on bone disease in hemodialysis pediatric patients in KAU Hospital, Jeddah Saudi Arabia: an experimental non-randomized study. http://www.ijmdc.com/?mno=74994 [Access: March 29, 2020]. doi:10.24911/IJMDC.51-1574511938


AMA (American Medical Association) Style

Safdar O, Jambi G, Asaad O, Hassan L, AlDahlawi L, Halawani AF, Jamjoom M, Shaikhoon B, Azhar A, Zaher ZF, Albokhari S, Shalaby M. L-Carnitine effect on bone disease in hemodialysis pediatric patients in KAU Hospital, Jeddah Saudi Arabia: an experimental non-randomized study. IJMDC. 2020; 4(3): 612-619. doi:10.24911/IJMDC.51-1574511938



Vancouver/ICMJE Style

Safdar O, Jambi G, Asaad O, Hassan L, AlDahlawi L, Halawani AF, Jamjoom M, Shaikhoon B, Azhar A, Zaher ZF, Albokhari S, Shalaby M. L-Carnitine effect on bone disease in hemodialysis pediatric patients in KAU Hospital, Jeddah Saudi Arabia: an experimental non-randomized study. IJMDC. (2020), [cited March 29, 2020]; 4(3): 612-619. doi:10.24911/IJMDC.51-1574511938



Harvard Style

Safdar, O., Jambi, . G., Asaad, . O., Hassan, . L., AlDahlawi, . L., Halawani, . A. F., Jamjoom, . M., Shaikhoon, . B., Azhar, . A., Zaher, . Z. F., Albokhari, . S. & Shalaby, . M. (2020) L-Carnitine effect on bone disease in hemodialysis pediatric patients in KAU Hospital, Jeddah Saudi Arabia: an experimental non-randomized study. IJMDC, 4 (3), 612-619. doi:10.24911/IJMDC.51-1574511938



Turabian Style

Safdar, Osama, Ghazal Jambi, Omar Asaad, Lujain Hassan, Lujain AlDahlawi, Abdalrashid F. Halawani, Mohammed Jamjoom, Bahaa Shaikhoon, Ahmad Azhar, Zaher F. Zaher, Shatha Albokhari, and Mohammed Shalaby. 2020. L-Carnitine effect on bone disease in hemodialysis pediatric patients in KAU Hospital, Jeddah Saudi Arabia: an experimental non-randomized study. International Journal of Medicine in Developing Countries, 4 (3), 612-619. doi:10.24911/IJMDC.51-1574511938



Chicago Style

Safdar, Osama, Ghazal Jambi, Omar Asaad, Lujain Hassan, Lujain AlDahlawi, Abdalrashid F. Halawani, Mohammed Jamjoom, Bahaa Shaikhoon, Ahmad Azhar, Zaher F. Zaher, Shatha Albokhari, and Mohammed Shalaby. "L-Carnitine effect on bone disease in hemodialysis pediatric patients in KAU Hospital, Jeddah Saudi Arabia: an experimental non-randomized study." International Journal of Medicine in Developing Countries 4 (2020), 612-619. doi:10.24911/IJMDC.51-1574511938



MLA (The Modern Language Association) Style

Safdar, Osama, Ghazal Jambi, Omar Asaad, Lujain Hassan, Lujain AlDahlawi, Abdalrashid F. Halawani, Mohammed Jamjoom, Bahaa Shaikhoon, Ahmad Azhar, Zaher F. Zaher, Shatha Albokhari, and Mohammed Shalaby. "L-Carnitine effect on bone disease in hemodialysis pediatric patients in KAU Hospital, Jeddah Saudi Arabia: an experimental non-randomized study." International Journal of Medicine in Developing Countries 4.3 (2020), 612-619. Print. doi:10.24911/IJMDC.51-1574511938



APA (American Psychological Association) Style

Safdar, O., Jambi, . G., Asaad, . O., Hassan, . L., AlDahlawi, . L., Halawani, . A. F., Jamjoom, . M., Shaikhoon, . B., Azhar, . A., Zaher, . Z. F., Albokhari, . S. & Shalaby, . M. (2020) L-Carnitine effect on bone disease in hemodialysis pediatric patients in KAU Hospital, Jeddah Saudi Arabia: an experimental non-randomized study. International Journal of Medicine in Developing Countries, 4 (3), 612-619. doi:10.24911/IJMDC.51-1574511938