Effect of Vitamin D Supplementation on Primary Dysmenorrhea: A Systematic Review and Meta-Analysis of Randomized Clinical Trials
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Search Strategy
2.3. Inclusion and Exclusion Criteria; PICO
2.4. Data Extraction, Synthesis, and Analysis
2.5. Quality Assessment and Risk of Bias (ROB)
2.6. Statistical Analysis
3. Results
3.1. Eligible Studies Flow Chart
3.2. Quality ROB
3.3. RCT Characteristics
3.4. Intervention Details and Outcome Measurements
3.5. Overall Effect Size (ES)
3.6. Subgroups Analysis
4. Discussion
4.1. Study Strengths
4.2. Study Limitation
5. Summary and Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
C | Comparator |
CI | Confidence interval |
CKAP2L | Cytoskeleton-associated protein 2-like |
COX-2 | Cyclooxygenase 2 |
GWAS | Genome-wide association studies |
I | Intervention |
IL | Interleukin |
JAK | Janus activated kinase |
KEGG | Kyoto Encyclopedia of Genes and Genomes |
MAPK | mitogen activated protein kinase |
MMPs | Matrix metalloproteinases |
NF-κB | Nuclear factor kappa B cell |
NRS | Numerical rating scale |
NSAIDs | Non-steroidal anti-inflammatory drugs |
O | Outcome |
OCPs | Oral contraceptive pills |
P | Population |
PCOS | Polycystic ovary syndrome |
PGs | Prostaglandins |
RCTs | Randomized clinical trials |
ROB | Risk-of-bias |
RoB 2 | Cochrane risk of bias |
SMD | Standardized mean difference |
SRMA | Systemic review meta-analysis |
STAT3 | Signal transducer and activator of transcription 3 |
TNF-α | Tumor necrosis factor-alpha |
V.C | Vasoconstriction |
VAS | Visual analogue scale |
VDR | Vitamin D receptor |
VEGF | Vascular endothelial growth factor |
Vit. D2 | Ergocalciferol |
Vit. D3 | Cholecalciferol |
Vit.D | Vitamin D |
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RCT Author Name Year [Ref.] | Bias | ||||
---|---|---|---|---|---|
Selection | Performance | Detection | Attrition | Reporting | |
Lasco 2012 [16] | ? | + | + | + | + |
Ataee 2015 [17] | + | + | + | + | + |
Moini 2016 [18] | ? | + | + | + | + |
Zarei 2016 [19] | + | + | + | + | + |
Begum 2017 [20] | + | ? | ? | + | + |
Pakniat 2019 [9] | + | + | − | + | + |
Lama 2019 [21] | + | − | − | + | + |
Rahnemaei 2021 [22] | + | + | + | + | + |
Amzajerdi 2023 [23] | + | + | + | + | + |
RCT Author Name Year [Ref.] | Study Country | Sample Size | Age Range (Years) | Menstrual Cycle Intervals (Days) | Assessment Tool/Scale | Blindness Design |
---|---|---|---|---|---|---|
Lasco A (2012) [16] | Italy | 40 | 18–40 | 21–35 | VAS | Double |
Ataee (2015) [17] | Iran | 54 | 18–30 | 21–35 | VAS | Double |
Moini A (2016) [18] | Iran | 50 | 18–30 | NA | VAS | Double |
Zarei S (2016) [19] | Iran | 85 | 18–32 | 21–35 | VAS | Double |
Begum (2017) [20] | India | 50 | 18–25 | 21–35 | VAS | Single |
Pakniat (2019) [9] | Iran | 200 | 18–25 | 21–35 | VAS | Single |
Lama (2019) [21] | Saudi Arabia | 22 | 13–40 | NA | VAS | Open-label |
Rahnemaei (2021) [22] | Iran | 116 | 18–32 | 22–35 | NRS | Double |
Amzajerdi (2023) [23] | Iran | 78 | 18–25 | 21–35 | VAS | Double |
RCT Author Name Year [Ref.] | Study Duration (Months) | Serum 25(OH)D Level | Primary Pain Score | Dosage Frequency | Dose Interval | Total Dose | Weekly Dose | Note/ Remarks | Significant Results for | ||
---|---|---|---|---|---|---|---|---|---|---|---|
Vit. D | Control | Vit. D | Control | IU | (Time) | IU | IU | ||||
Lasco A (2012) [16] | 0 | 27.2 ± 7.5 | 29.9 ± 7.6 | 5.85 ± 2.0 | 5.6 ± 1.9 | 300,000 single | month | 600,000 | 75,000 | Control/placebo pill Intervention time: 5 days before next period | D |
1 | NA | NA | 3.7 ± 1.34 | 5.4 ± 1.8 | |||||||
2 | NA | NA | 3.5 ± 1.3 | 5.7 ± 1.6 | |||||||
Ataee (2015) [17] | 0 | 7.3 ± 3.6 | 6.3 ± 2.8 | 7.13 ± 1.85 | 7.38 ± 1.56 | 300,000 single | month | 900,000 | 75,000 | Control/placebo pill Intervention time: 5 days before next period | D |
1 | NA | NA | 5.30 ± 2.24 | 5.21 ± 2.35 | |||||||
2 | NA | NA | 3.97 ± 1.90 | 5.24 ± 2.27 | |||||||
3 | NA | NA | 3.77 ± 1.77 | 5.55 ± 2.02 | |||||||
Moini A (2016) [18] | 0 | 9.7 ± 5.09 | 11.5 ± 3.7 | 8.50 | 9.60 | 50,000 weekly | week | 400,000 | 50,000 | Control/placebo pill | D |
2 | 55.4 ± 6.02 | 13.57 ± 4 | 2.50 | 7.60 | |||||||
Zarei S (2016) [19] | 0 | NA | NA | 6.20 ± 1.60 | 6.30 ± 1.80 | 5000 | day | 300,000 | 25,000 | Control/placebo + 1000 mg Ca Intervention time: 20 days /menstruation period | Ca > Ca + D >placebo |
1 | 5.40 ± 2.30 | 4.7 ± 2.30 | |||||||||
2 | 4.70 ± 2.20 | 4.2 ± 2.20 | |||||||||
3 | 4.60 ± 2.60 | 3.6 ± 2.20 | |||||||||
4 | 5.00 ± 2.60 | 3.9 ± 2.50 | |||||||||
Begum (2017) [20] | 0 | 17.8 ± 10.1 | 19.10 | 8.76 ± 0.97 | 8.80 ± 0.95 | 300,000 single | once | 300,000 | 18,750 | Control/placebo pill | D |
2 | NA | NA | 2.72 ± 1.17 | 8.20 ± 0.74 | |||||||
4 | 34.7 ± 8.1 | 19.34 | 3.56 ± 0.76 | 8.20 ± 0.74 | |||||||
Pakniat (2019) [9] | 0 | NA | NA | 7.01 ± 0.11 | 7.24 ± 0.56 | 3000 | month | 6000 | 750 | Vit D: 3000 IU + 500 mg mefenamic acid | D |
2 | NA | NA | 5.20 ± 1.34 | 6.00 ± 0.70 | Control/placebo + 500 mg mefenamic | ||||||
Lama (2019) [21] | 0 | 30.1 ± 13.4 | 19.5 ± 5.5 | 7.8 ± 1 | 6.9 ± 1.2 | 50,000 | week | 400,000 | 50,000 | Vit D: 50,000 IU + NSAID Control: NSAID | D |
2 | 80.2 ± 14.3 | 19.70 ± 5.6 | 3.6 ± 1.2 | 6.4 ± 1.1 | |||||||
Rahnemaei (2021) [22] | 0 | 20 ± 6 | 19.5 ± 5.5 | 7.0 ± 1.7 | 6.6 ± 1.5 | 50,000 | week | 400,000 | 50,000 | Vit D: 50,000 IU +NSAID or acetaminophen | D |
2 | 37.2 ± 9.4 | 19.7 ± 5.6 | 5.6 ± 1.7 | 6.5 ± 1.6 | |||||||
Amzajerdi (2023) [23] | 0 | 5.10 ± 3.31 | 6.6 ± 5.63 | 6.71 ± 2.25 | 6.64 ± 2.46 | 300,000 single | once | 300,000 | 18,750 | Control/placebo pill | D |
1 | 30.63 ± 5.43 | 9.73 ± 4.72 | 5.33 ± 2.39 | 6.53 ± 2.30 | |||||||
2 | 3.92 ± 2.36 | 6.79 ± 2.17 |
Subgroup | SMD | 95% CI |
---|---|---|
Total dose | ||
Average weekly ≥ 50,000 IU | ||
a. Total dose ≥ 400,000 | −1.056 * | −1.619 to −0.493 |
b. Total dose < 400,000 | NA | NA |
Heterogeneity (Tau2 = 0.225, df (Q) = 3 (p = 0.013), I2 = 72.287%) | ||
Average weekly < 50,000 IU | ||
a. Total dose ≥ 400,000 | NA | NA |
b. Total dose < 400,000 | −1.709 * | −2.947 to −0.472 |
Heterogeneity (Tau2 = 1.851, df (Q) = 4 (p = 0.000), I2 = 95.569%) | ||
Study duration | ||
Average weekly ≥ 50,000 IU | ||
a. Study duration ≥ 70 days | −0.937 * | −1.499 to −0.375 |
Heterogeneity (Tau2 = 0.000, df (Q) = 0 (p = 1.000), I2 = 0.000%) | ||
b. Study duration < 70 days | −1.171 * | −2.007 to −0.334 |
Heterogeneity (Tau2 = 0.422, df (Q) = 2 (p = 0.005), I2 = 81.236%) | ||
Average weekly < 50,000 IU | ||
a. Study duration ≥ 70 days | −2.856 | −9.324 to 3.612 |
Heterogeneity (Tau2 = 21.518, df (Q) = 1 (p = 0.000), I2 = 98.773%) | ||
b. Study duration < 70 days | −1.122 * | −1.578 to −0.666 |
Heterogeneity (Tau2 = 0.092, df (Q) = 2 (p = 0.097), I2 = 57.066%) | ||
Dose interval | ||
Average weekly ≥ 50,000 IU | ||
a. Monthly or once | −0.937 * | −1.499 to −0.375 |
Heterogeneity (Tau2 = 0.000, df (Q) = 0 (p = 1.000), I2 = 0.000%) | ||
b. Weekly or daily | −1.171 * | −2.007 to −0.334 |
Heterogeneity (Tau2 = 0.422, df (Q) = 2 (p = 0.005), I2 = 81.236%) | ||
Average weekly < 50,000 IU | ||
a. Monthly or once | −2.258 * | −3.617 to −0.899 |
Heterogeneity (Tau2 = 1.762, df (Q) = 3 (p = 0.000), I2 = 94.925%) | ||
b. Weekly or daily | 0.415 | −0.110 to 0.939 |
Heterogeneity (Tau2 = 0.000, df (Q) = 0 (p = 1.000), I2 = 0.000%) |
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Chen, Y.-C.; Chiang, Y.-F.; Lin, Y.-J.; Huang, K.-C.; Chen, H.-Y.; Hamdy, N.M.; Huang, T.-C.; Chang, H.-Y.; Shieh, T.-M.; Huang, Y.-J.; et al. Effect of Vitamin D Supplementation on Primary Dysmenorrhea: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Nutrients 2023, 15, 2830. https://doi.org/10.3390/nu15132830
Chen Y-C, Chiang Y-F, Lin Y-J, Huang K-C, Chen H-Y, Hamdy NM, Huang T-C, Chang H-Y, Shieh T-M, Huang Y-J, et al. Effect of Vitamin D Supplementation on Primary Dysmenorrhea: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Nutrients. 2023; 15(13):2830. https://doi.org/10.3390/nu15132830
Chicago/Turabian StyleChen, Yi-Chun, Yi-Fen Chiang, Ying-Jiun Lin, Ko-Chieh Huang, Hsin-Yuan Chen, Nadia M. Hamdy, Tsui-Chin Huang, Hsin-Yi Chang, Tzong-Ming Shieh, Yun-Ju Huang, and et al. 2023. "Effect of Vitamin D Supplementation on Primary Dysmenorrhea: A Systematic Review and Meta-Analysis of Randomized Clinical Trials" Nutrients 15, no. 13: 2830. https://doi.org/10.3390/nu15132830