A systematic review of pediatric clinical trials of high dose vitamin D
Background. Due to inadequate UV exposure, intake of small quantities of vitamin D is recommended to prevent musculoskeletal disease. Both basic science and observational literature strongly suggest that higher doses may benefit specific populations and have non-musculoskeletal roles. Evaluating the...
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PeerJ Inc.
2016-02-01
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| Online dostop: | https://peerj.com/articles/1701.pdf |
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| author | Nassr Nama Kusum Menon Klevis Iliriani Supichaya Pojsupap Margaret Sampson Katie O’Hearn Linghong (Linda) Zhou Lauralyn McIntyre Dean Fergusson James D. McNally |
| author_facet | Nassr Nama Kusum Menon Klevis Iliriani Supichaya Pojsupap Margaret Sampson Katie O’Hearn Linghong (Linda) Zhou Lauralyn McIntyre Dean Fergusson James D. McNally |
| author_sort | Nassr Nama |
| collection | DOAJ |
| description | Background. Due to inadequate UV exposure, intake of small quantities of vitamin D is recommended to prevent musculoskeletal disease. Both basic science and observational literature strongly suggest that higher doses may benefit specific populations and have non-musculoskeletal roles. Evaluating the evidence surrounding high dose supplementation can be challenging given a relatively large and growing body of clinical trial evidence spanning time, geography, populations and dosing regimens. Study objectives were to identify and summarize the clinical trial literature, recognize areas with high quality evidence, and develop a resource database that makes the literature more immediately accessible to end users. Methods. Medline (1946 to January 2015), Embase (1974 to January 2015), and Cochrane databases (January 2015), were searched for trials. All pediatric (0–18 years) trials administering doses higher than 400 IU (<1 year) or 600 IU (≥1 year) were included. Data was extracted independently by two of the authors. An online searchable database of trials was developed containing relevant extracted information (http://www.cheori.org/en/pedvitaminddatabaseOverview). Sensitivity and utility were assessed by comparing the trials in the database with those from systematic reviews of vitamin D supplementation including children. Results. A total of 2,579 candidate papers were identified, yielding 169 trials having one or more arms meeting eligibility criteria. The publication rate has increased significantly from 1 per year (1970–1979) to 14 per year (2010–2015). Although 84% of the total trials focused on healthy children or known high risk populations (e.g., renal, prematurity), this proportion has declined in recent years due to the rise in trials evaluating populations and outcomes not directly related to the musculoskeletal actions of vitamin D (27% in 2010s). Beyond healthy children, the only pediatric populations with more than 50 participants from low risk of bias trials evaluating a clinically relevant outcome were prematurity and respiratory illness. Finally, we created and validated the online searchable database using 13 recent systematic reviews. Of the 38 high dose trials identified by the systematic review, 36 (94.7%) could be found within the database. When compared with the search strategy reported in each systematic review, use of the database reduced the number of full papers to assess for eligibility by 85.2% (±13.4%). Conclusion. The pediatric vitamin D field is highly active, with a significant increase in trials evaluating non-classical diseases and outcomes. Despite the large overall number there are few high quality trials of sufficient size to provide answers on clinical efficacy of high-dose vitamin D. An open access online searchable data should assist end users in the rapid and comprehensive identification and evaluation of trials relevant to their population or question of interest. |
| first_indexed | 2024-03-09T06:40:17Z |
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| language | English |
| last_indexed | 2024-03-09T06:40:17Z |
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| spelling | doaj.art-7306b9fb11d54922ac74e5b0124b2da22023-12-03T10:51:47ZengPeerJ Inc.PeerJ2167-83592016-02-014e170110.7717/peerj.1701A systematic review of pediatric clinical trials of high dose vitamin DNassr Nama0Kusum Menon1Klevis Iliriani2Supichaya Pojsupap3Margaret Sampson4Katie O’Hearn5Linghong (Linda) Zhou6Lauralyn McIntyre7Dean Fergusson8James D. McNally9Faculty of Medicine, University of Ottawa, Ottawa, Ontario, CanadaDepartment of Pediatrics, Children’s Hospital of Eastern Ontario, Ottawa, Ontario, CanadaSchool of Medicine, Trinity College, Dublin, IrelandDepartment of Pediatrics, Children’s Hospital of Eastern Ontario, Ottawa, Ontario, CanadaDepartment of Volunteers, Communication and Information Resources, Children’s Hospital of Eastern Ontario, Ottawa, Ontario, CanadaDepartment of Pediatrics, Children’s Hospital of Eastern Ontario, Ottawa, Ontario, CanadaFaculty of Medicine, University of Ottawa, Ottawa, Ontario, CanadaOttawa Hospital Research Institute, Ottawa, Ontario, CanadaClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaFaculty of Medicine, University of Ottawa, Ottawa, Ontario, CanadaBackground. Due to inadequate UV exposure, intake of small quantities of vitamin D is recommended to prevent musculoskeletal disease. Both basic science and observational literature strongly suggest that higher doses may benefit specific populations and have non-musculoskeletal roles. Evaluating the evidence surrounding high dose supplementation can be challenging given a relatively large and growing body of clinical trial evidence spanning time, geography, populations and dosing regimens. Study objectives were to identify and summarize the clinical trial literature, recognize areas with high quality evidence, and develop a resource database that makes the literature more immediately accessible to end users. Methods. Medline (1946 to January 2015), Embase (1974 to January 2015), and Cochrane databases (January 2015), were searched for trials. All pediatric (0–18 years) trials administering doses higher than 400 IU (<1 year) or 600 IU (≥1 year) were included. Data was extracted independently by two of the authors. An online searchable database of trials was developed containing relevant extracted information (http://www.cheori.org/en/pedvitaminddatabaseOverview). Sensitivity and utility were assessed by comparing the trials in the database with those from systematic reviews of vitamin D supplementation including children. Results. A total of 2,579 candidate papers were identified, yielding 169 trials having one or more arms meeting eligibility criteria. The publication rate has increased significantly from 1 per year (1970–1979) to 14 per year (2010–2015). Although 84% of the total trials focused on healthy children or known high risk populations (e.g., renal, prematurity), this proportion has declined in recent years due to the rise in trials evaluating populations and outcomes not directly related to the musculoskeletal actions of vitamin D (27% in 2010s). Beyond healthy children, the only pediatric populations with more than 50 participants from low risk of bias trials evaluating a clinically relevant outcome were prematurity and respiratory illness. Finally, we created and validated the online searchable database using 13 recent systematic reviews. Of the 38 high dose trials identified by the systematic review, 36 (94.7%) could be found within the database. When compared with the search strategy reported in each systematic review, use of the database reduced the number of full papers to assess for eligibility by 85.2% (±13.4%). Conclusion. The pediatric vitamin D field is highly active, with a significant increase in trials evaluating non-classical diseases and outcomes. Despite the large overall number there are few high quality trials of sufficient size to provide answers on clinical efficacy of high-dose vitamin D. An open access online searchable data should assist end users in the rapid and comprehensive identification and evaluation of trials relevant to their population or question of interest.https://peerj.com/articles/1701.pdfHigh-dosePediatricsVitamin DSystematic reviewOnline database |
| spellingShingle | Nassr Nama Kusum Menon Klevis Iliriani Supichaya Pojsupap Margaret Sampson Katie O’Hearn Linghong (Linda) Zhou Lauralyn McIntyre Dean Fergusson James D. McNally A systematic review of pediatric clinical trials of high dose vitamin D PeerJ High-dose Pediatrics Vitamin D Systematic review Online database |
| title | A systematic review of pediatric clinical trials of high dose vitamin D |
| title_full | A systematic review of pediatric clinical trials of high dose vitamin D |
| title_fullStr | A systematic review of pediatric clinical trials of high dose vitamin D |
| title_full_unstemmed | A systematic review of pediatric clinical trials of high dose vitamin D |
| title_short | A systematic review of pediatric clinical trials of high dose vitamin D |
| title_sort | systematic review of pediatric clinical trials of high dose vitamin d |
| topic | High-dose Pediatrics Vitamin D Systematic review Online database |
| url | https://peerj.com/articles/1701.pdf |
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