Trial reportThe Journal of pediatrics2016
Treatment of Vitamin D Deficiency in Predominantly Hispanic and Black Adolescents: A Randomized Clinical Trial.
Trial report in The Journal of pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
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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.
Comparison of Two Standard High-dose Treatment Regimens for Vitamin D Deficiency in Minority Adolescents: Associations of Vitamin D Repletion With Changes in Markers of Musculoskeletal, Cardiometabolic, and Immune Function
Vitamin D Supplementation in Patients With Operated Tibia Fracture and Low Vitamin D. Does it Improve Healing Rate?. Randomized Controlled Trial
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Effect of vitamin D supplementation on serum vitamin D levels and health outcomes in pediatric population with obesity/overweight: a systematic review and meta-analysis.International journal of obesity (2005) · 2026Pooled it
- Interventions to improve vitamin D status in at-risk ethnic groups during pregnancy and early childhood: a systematic review.Public health nutrition · 2021Pooled it
- Daily vitamin DEuropean journal of nutrition · 2021Trial
- Hypovitaminosis D in persons with Down syndrome and autism spectrum disorder.Journal of neurodevelopmental disorders · 2023Article
- Perspective: School Meal Programs Require Higher Vitamin D Fortification Levels in Milk Products and Plant-Based Alternatives-Evidence from the National Health and Nutrition Examination Surveys (NHANES 2001-2018).Advances in nutrition (Bethesda, Md.) · 2022Article
- Effects of Supplementation in Vitamin D3 Deficient or Insufficient Children with Allergic Diseases.Medicina (Kaunas, Lithuania) · 2021Observational
- Recruitment and retention in randomized controlled trials with urban American Indian/Alaska Native adolescents: Challenges and lessons learned.Clinical trials (London, England) · 2021Article
- Influence of Genetic Ancestry on Human Serum Proteome.American journal of human genetics · 2020Article
- Treatment with Vitamin D3 in Vitamin D Deficient Adolescents: A Pilot Study.Global pediatric health · 2020Article
- Interventions for Prevention and Control of Epidemic of Vitamin D Deficiency.Indian journal of pediatrics · 2019Review
- Vitamin D in pediatric age: consensus of the Italian Pediatric Society and the Italian Society of Preventive and Social Pediatrics, jointly with the Italian Federation of Pediatricians.Italian journal of pediatrics · 2018Review
- Weight and skin colour as predictors of vitamin D status: results of an epidemiological investigation using nationally representative data.Public health nutrition · 2017Article
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 1 institution in 1 country.
Funding
Abstract
objectivesTo compare 3 different treatment regimens for vitamin D deficiency in minority adolescents and to explore factors that impact treatment efficacy. STUDY
designWe conducted an 8-week, prospective, open-label, randomized clinical trial in an urban, academic, children's hospital. A total of 183 vitamin D-deficient adolescents, mean 25-hydroxyvitamin D or 25(OH)D 13.7 ± 3.9 ng/mL; mean age 16.6 ± 2.2 years, were randomized into 3 vitamin D3 (cholecalciferol) treatment arms: 50,000 IU/wk; 5000 IU/d; and 1000 IU/d. Serum 25(OH)D and vitamin D binding protein (VDBP) levels were measured pre-and posttreatment; 122 (67%) participants completed posttreatment measures. Complete-case and multiple-imputation, intention-to-treat analyses were performed.
resultsMean change in 25(OH)D level posttreatment was significantly different among the 3 arms, 24.9 ± 15.1 vs 21.0 ± 15.2 vs 6.2 ± 6.5 ng/mL, for 50,000 IU, 5000 IU, and 1000 IU doses, respectively, P < .001. Both high-dose treatments were effective in increasing the 25(OH)D level out of deficiency range (≥ 20 ng/mL) in more than 80% of participants, and 60% remained deficient after low-dose treatment. Only 72%, 56%, and 2% achieved vitamin D sufficiency (>30 ng/mL) with 50,000 IU, 5000 IU, and 1000 IU doses, respectively, P < .001. Obese participants had substantially less mean change in 25(OH)D level after treatment than normal-weight participants, 13.7 ± 10.7 vs 21.9 ± 16.9 ng/mL, P < .001. Mean baseline VDBP level was almost twice as high in Hispanic compared with black participants (P < .001) and did not alter treatment response or change with treatment.
conclusionsAdult-sized adolescents require 8 weeks of high-dose cholecalciferol, at least 5000 IU/d, to correct deficiency. Obese adolescents have poorer response to treatment and may need higher doses than nonobese youth. Hispanic and black adolescents have different VDBP levels but similar treatment responses.
trial registrationClinicalTrials.gov: NCT01784029.
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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.