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. 2023 Apr 6;13:12. doi: 10.5334/tohm.741

Table 1.

Summary of studies examining vitamin D levels and restless legs syndrome.


VITAMIN D LEVELS IN PEOPLE WITH RLS

AUTHOR YEAR STUDY TYPE POPULATION CRITERIA FOR VITAMIN D DEFICIENCY GROUPS DIAGNOSTIC/ELIGIBILITY CRITERIA FOR RLS RLS DIAGNOSIS METHOD SAMPLE SIZE N (%) VITAMIN D DEFICIENT VITAMIN D LEVELS (NG/ML) NOTES

Wali 2018 [8] Case-Control Healthy Adults <50 nmol/L (<20 ng/mL) All RLS 2014 IRLSSG [116] Study-specific questionnaire for diagnostic criteria and associated mimics [116] along with neurological examination of lower limbs 78 59 (75.6%) 12.7 ± 7.0 Secondary analysis controlled for comorbid/clinical conditions


Primary RLS 50 37 (74.0%) Not reported


Secondary RLS 28 6 (21.4%) Not reported


Controls Age- and sex-matched at frequency of 2:1 control:RLS ratio 123 52 (42.3%) 26.1 ± 9.9

Jiménez-Jiménez 2021 [16] Case-Control Healthy Adults N/A RLS 2014 IRLSSG [116] Clinical interview in most participants; excluded secondary causes of RLS; excluded conditions: liver, kidney, thyroid and parathyroid diseases, and obesity 285 N/A 21.9 ± 9.7 Excluded participants with known vitamin D deficiency


Controls Age- and sex-matched 325 N/A 18.6 ± 9.8

Liu 2021 [15] Case-Control Healthy Adults <50 nmol/L (<20 ng/mL) All RLS 2014 IRLSSG [116] Physician interview; excluded secondary causes of RLS, other sleep disorders, diseases that affect vitamin D levels, people taking medications that affect vitamin D levels or drugs that alleviate RLS, and pregnant/lactating women 57 46 (81%) 16.1 ± 5.4


Mild-Moderate RLS 36 Not reported 17.3 ± 5.4


Severe RLS 21 Not reported 14.0 ± 4.9


Controls Age- and sex-matched 57 1 (2%) 27.0 ± 5.0

Balaban 2012 [17] Case-Control Healthy Adults N/A RLS Females 1995 IRLSSG [117] Clinical interview; no comorbidities and normal neurological examination; excluded known causes of secondary RLS, a familial history of RLS, or any medical conditions that would affect the assessment of RLS 28 Not reported 7.3 ± 4.6


RLS Males 8 Not reported 11.4 ± 6.2


Control Females Age- and sex-matched 27 Not reported 12.3 ± 5.3


Control Males 11 Not reported 13.0 ± 5.4

Almeneessier 2020a [19] Case-Control Pregnant Women Normal:
Insufficient:
Pregnant RLS 2014 IRLSSG [116] Clinical interview by trained medical students; excluded conditions that could mimic RLS 223 47 (21.0%) Not reported

Pregnant Control N/A N/A 519 66 (12.7%) Not reported

Miyazaki 2023 [20] Case-Control Pregnant Women <10 ng/mL and <20 ng/mL Pregnant RLS ICSD 3rd [118] Clinical Phone Interview with Japanese version of CH-RLSq13 [119] 35 LC-MS/MS <10: 12 (34.3%)
LC-MS/MS <20: 33 (94.3%)
LC-MS/MS: 11.4 (7.0) Serum 25(OH)D levels reported as median (IQR)
Two different methods of quantifying levels: LC-MS/MS and CLEIA
CLEIA <10: 24 (68.6%)
CLEIA <20: 25 (100%)
CLEIA: 7.2 (6.1)

Pregnant Controls N/A N/A 168 LC-MS/MS <10: 24 (14.3%)
LC-MS/MS <20: 129 (76.8%)
LC-MS/MS: 15.4 (8.1)
CLEIA <10: 25 (50.6%)
CLEIA <20: 158 (94.0%)
CLEIA: 9.8 (6.3)

Almeneessier 2020b [21] Case-Control Non-pregnant Women < 25 nmol/L Non-pregnant RLS 2014 IRLSSG [116] Clinical interview by trained professionals; excluded comorbid conditions that could mimic RLS and other sleep disorders 271 173 (63.8%) Not reported

Non-pregnant Control N/A N/A 865 390 (45.1%) Not reported

Bener 2019 [22] Case-Control Type II Diabetes Mellitus (T2DM) Deficient: <20 ng/mL
Insufficient: 20-29 ng/mL
Sufficient: >30 ng/mL
T2DM RLS Not reported Not reported 199 Deficient: 122 (61.3%)
Insufficient: 43 (21.6%)
Sufficient:
34 (17.1%)
7.7 ± 3.6

T2DM No RLS N/A N/A 672 Deficient: 289 (43.0%)
Insufficient: 214 (31.8%)
Sufficient: 169 (25.1%)
8.7 ± 3.8

Evans 2018 [25] Case-Control Healthy Pediatric (3-12 years) Deficient: <10 ng/mL
Insufficient: 11-30 ng/mL
Normal: 31-75 ng/mL
RLS “Yes” to relief from movement Leg pain questionnaire [120] 12 Deficient:
5 (41.7%)
Insufficient:
4 (33.3%)
Normal:
3 (25.0%)
15.3 (5.3–61.8) Vitamin D levels presented as median (minimum-maximum)


GP “Yes” to questions 1-5 28 Deficient:
4 (14.3%)
Insufficient:
20 (71.4%)
Normal:
4 (14.3%)
19.7 (4.2–59.3)


GP+RLS “Yes” to questions 1-5 and 9 37 Deficient:
10 (27.0%)
Insufficient:
24 (64.9%)
Normal:
3 (8.1%)
12.8 (4.5–60.7)


Controls Age- and gender-matched 13 Deficient:
4 (30.8%)
Insufficient:
7 (53.8%)
Normal:
2 (15.4%)
15.6 (7.9–61.8)

Işıkay 2018 [27] Case-Control Pediatrics (11–18 years) with Celiac Disease N/A Celiac RLS IRLSSG criteria (version not specified) Questionnaire – questions/methods otherwise not specified 8 N/A 9.9 ± 4.7 “No patient previously diagnosed with RLS was included in or excluded from the study”
RLS severity was negatively associated with serum vitamin D levels

Celiac no RLS 218 N/A 12.5 ± 11.7

RLS IN PEOPLE WITH VITAMIN D DEFICIENCY

AUTHOR YEAR STUDY TYPE POPULATION VITAMIN D STATUS GROUPS DIAGNOSTIC/ELIGIBILITY CRITERIA FOR RLS RLS DIAGNOSIS METHOD SAMPLE SIZE (N) N (%) RLS VITAMIN D LEVELS (NG/ML) NOTES

Çakır 2015 [28] Case-Control Healthy Adults <20 ng/mL VDD 2003 IRLSSG 4 criteria [29] Survey (method not specified); excluded diabetes, vitamin B12 deficiency, chronic renal failure, anemia, and use of any medications that could mimic RLS 57 30 (52.6%) N/A


>20 ng/mL Controls 45 17 (37.7%) N/A

Oran 2014 [10] Case-Control Healthy Adults <20 ng/mL VDD 2003 IRLSSG 4 criteria [29] Neurologist Evaluation; excluded abnormal levels of ferritin or with a known condition to cause secondary RLS and people with a family history of RLS (among others) 119 60 (50.4%) 11.2 ± 4.7


>20 ng/mL Controls 36 6 (16.7%) 34.2 ± 10.0

Olama 2013 [23] Case-Control Premenopausal women with primary fibromyalgia syndrome (PFMS) ≤20 ng/mL PFMS VDD 2003 IRLSSG 4 criteria [29] Clinical evaluation; Jenkins’ Sleep Questionnaire [121]; excluded inflammatory rheumatic disease, known osteoporosis,
treated with antiresorptive drugs, renal disease, hepatic disease, malabsorption disorder, anticonvulsant therapy,
malignancy and pregnancy
28 16 (57.1%) Not reported


>20 ng/mL PFMS Controls 22 6 (27.3%) Not reported

Note: RLS restless legs syndrome; IRLSSG International Restless Legs Syndrome Study Group; N/A not applicable; ICSD International Classification of Sleep Disorders; CH-RLSq13 Cambridge-Hopkins Restless Legs Syndrome Short Form Diagnostic Questionnaire; LC-MS/MS liquid chromatography–tandem mass spectrometry; CLEIA chemiluminescent enzyme immunoassay; IQR interquartile range; T2DM type II diabetes mellitus; GP growing pains; VDD vitamin D deficiency; PFMS primary fibromyalgia syndrome.