Trial reportJournal of pediatric hematology/oncology2015
Safety and Efficacy of High-dose Daily Vitamin D3 Supplementation in Children and Young Adults With Sickle Cell Disease.
Trial report in Journal of pediatric hematology/oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Interventions to improve vitamin D status in at-risk ethnic groups during pregnancy and early childhood: a systematic review.Public health nutrition · 2021Pooled it
- Vitamin D supplementation for sickle cell disease.The Cochrane database of systematic reviews · 2020Pooled it
- Vitamin D supplementation for sickle cell disease.The Cochrane database of systematic reviews · 2017Pooled it
- Safety and efficacy of monthly high-dose vitamin DEuropean journal of pediatrics · 2024Trial
- Muscle Strength, Power, and Torque Deficits in Children With Type SS Sickle Cell Disease.Journal of pediatric hematology/oncology · 2018Trial
- Vitamin D Supplementation Improves Health-Related Quality of Life and Physical Performance in Children with Sickle Cell Disease and in Healthy Children.Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & PractitionersTrial
- High dose dietary vitamin D allocates surplus calories to muscle and growth instead of fat via modulation of myostatin and leptin signaling.Research square · 2024Article
- Palatability and Acceptability of Flaxseed-Supplemented Foods in Children with Sickle Cell Disease.Nutrients · 2023Article
- Clinical Vignettes, Part II: Eyes, Teeth, and Bone.Hematology/oncology clinics of North America · 2022Review
- Prevalence of Vitamin D Deficiency Varies Widely by Season in Canadian Children and Adolescents with Sickle Cell Disease.Journal of clinical medicine · 2018Article
- Serum Thymidine Kinase 1, Canine-C-Reactive Protein, Haptoglobin, and Vitamin D Concentrations in Dogs with Immune-Mediated Hemolytic Anemia, Thrombocytopenia, and Polyarthropathy.Journal of veterinary internal medicine · 2017Article
- A pilot validation study of crowdsourcing systematic reviews: update of a searchable database of pediatric clinical trials of high-dose vitamin D.Translational pediatrics · 2017Article
- Nutritional Modulation of Gene Expression: Might This be of Benefit to Individuals with Crohn's Disease?Frontiers in immunology · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
Abstract
Suboptimal vitamin D (vit D) status (<32 ng/mL) is ubiquitous among African American children with type SS sickle cell disease (SCD-SS). The vit D supplemental dose to normalize vit D status is unknown. Five to 20-year-old African American children with (n=21) and without (n=23) SCD-SS were randomized to vit D3 supplementation (4000 or 7000 IU/d) and evaluated at 6 and 12 weeks for changes in vit D and SCD status. A dose was considered unsafe if serum calcium was elevated associated with elevated serum 25 hydroxyvitamin D (25(OH)D). At baseline 95% of subjects with SCD-SS and 87% of healthy controls had suboptimal vit D status (mean±SD, 19.2±7.2 and 22.3±9.3 ng/mL, respectively). After 12 weeks supplementation, both D3 doses were safe and well tolerated. Neither group achieved the a priori efficacy criterion of 25(OH)D≥32 ng/mL in >80% of subjects (45% in SCD-SS and 63% in controls). However, for both subjects with SCD-SS and healthy subjects by 12 weeks, deficient (<20 ng/mL) vit D status was eliminated only in those receiving 7000 IU/d. For subjects with SCD-SS, by 12 weeks there was a significant (all P<0.05) increase in fetal hemoglobin, decrease in high-sensitivity C-reactive protein, and reduction in the percentage of subjects with a high platelet count.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.