Carlos A Camargo1, D Ganmaa2, Robert Sidbury3, Kh Erdenedelger4, N Radnaakhand5, B Khandsuren4. 1. Massachusetts General Hospital, Harvard Medical School, and Harvard School of Public Health, Boston, Mass. Electronic address: ccamargo@partners.org. 2. Massachusetts General Hospital, Harvard Medical School, and Harvard School of Public Health, Boston, Mass; Health Sciences University of Mongolia, Ulaanbaatar, Mongolia. 3. Seattle Children's Hospital, Seattle, Wash. 4. Health Sciences University of Mongolia, Ulaanbaatar, Mongolia; National Dermatology Center, Ulaanbaatar, Mongolia. 5. Health Sciences University of Mongolia, Ulaanbaatar, Mongolia.
Abstract
BACKGROUND: Epidemiologic and preclinical data, and a small randomized trial in Boston, suggest that vitamin D supplementation may improve winter-related atopic dermatitis (AD). OBJECTIVE: To determine the effect of vitamin D supplementation on winter-related AD. METHODS: We performed a randomized, double-blind, placebo-controlled trial of Mongolian children with winter-related AD (clinicaltrials.gov identifier: NCT00879424). Baseline eligibility included age 2 to 17 years, AD score 10 to 72 using the Eczema Area and Severity Index (EASI), and winter-related AD (eg, history of AD worsening during the fall-to-winter transition). Subjects were enrolled in Ulaanbaatar during winter and randomly assigned to oral cholecalciferol (1000 IU/day) versus placebo for 1 month. All children and parents received emollient and patient education about AD and basic skin care. The main outcomes were changes in EASI score and in Investigator's Global Assessment. RESULTS: The 107 enrolled children had a mean age of 9 years (SD 5), and 59% were male. Their median age of AD onset was 3 months (interquartile range 2 months to 1 year) and mean EASI score at baseline 21 (SD 9). One-month follow-up data were available for 104 (97%) children. Compared with placebo, vitamin D supplementation for 1 month produced a clinically and statistically significant improvement in EASI score (adjusted mean change: -6.5 vs -3.3, respectively; P = .04). Moreover, change in Investigator's Global Assessment favored vitamin D over placebo (P = .03). There were no adverse effects in either group. CONCLUSION:Vitamin D supplementation improved winter-related AD among Mongolian children, a population likely to have vitamin D deficiency in winter.
RCT Entities:
BACKGROUND: Epidemiologic and preclinical data, and a small randomized trial in Boston, suggest that vitamin D supplementation may improve winter-related atopic dermatitis (AD). OBJECTIVE: To determine the effect of vitamin D supplementation on winter-related AD. METHODS: We performed a randomized, double-blind, placebo-controlled trial of Mongolian children with winter-related AD (clinicaltrials.gov identifier: NCT00879424). Baseline eligibility included age 2 to 17 years, AD score 10 to 72 using the Eczema Area and Severity Index (EASI), and winter-related AD (eg, history of AD worsening during the fall-to-winter transition). Subjects were enrolled in Ulaanbaatar during winter and randomly assigned to oral cholecalciferol (1000 IU/day) versus placebo for 1 month. All children and parents received emollient and patient education about AD and basic skin care. The main outcomes were changes in EASI score and in Investigator's Global Assessment. RESULTS: The 107 enrolled children had a mean age of 9 years (SD 5), and 59% were male. Their median age of AD onset was 3 months (interquartile range 2 months to 1 year) and mean EASI score at baseline 21 (SD 9). One-month follow-up data were available for 104 (97%) children. Compared with placebo, vitamin D supplementation for 1 month produced a clinically and statistically significant improvement in EASI score (adjusted mean change: -6.5 vs -3.3, respectively; P = .04). Moreover, change in Investigator's Global Assessment favored vitamin D over placebo (P = .03). There were no adverse effects in either group. CONCLUSION:Vitamin D supplementation improved winter-related AD among Mongolian children, a population likely to have vitamin D deficiency in winter.
Authors: Giuseppe Saggese; Francesco Vierucci; Annemieke M Boot; Justyna Czech-Kowalska; Giovanna Weber; Carlos A Camargo; Eric Mallet; Margherita Fanos; Nick J Shaw; Michael F Holick Journal: Eur J Pediatr Date: 2015-04-02 Impact factor: 3.183
Authors: Giuseppe Saggese; Francesco Vierucci; Flavia Prodam; Fabio Cardinale; Irene Cetin; Elena Chiappini; Gian Luigi De' Angelis; Maddalena Massari; Emanuele Miraglia Del Giudice; Michele Miraglia Del Giudice; Diego Peroni; Luigi Terracciano; Rino Agostiniani; Domenico Careddu; Daniele Giovanni Ghiglioni; Gianni Bona; Giuseppe Di Mauro; Giovanni Corsello Journal: Ital J Pediatr Date: 2018-05-08 Impact factor: 2.638
Authors: Maria Blomberg; Sheryl L Rifas-Shiman; Carlos A Camargo; Diane R Gold; Maryam M Asgari; Jacob P Thyssen; Augusto A Litonjua; Matthew W Gillman; Emily Oken Journal: J Invest Dermatol Date: 2017-02-12 Impact factor: 8.551
Authors: Teruaki Nakatsuji; Tiffany H Chen; Aimee M Two; Kimberly A Chun; Saisindhu Narala; Raif S Geha; Tissa R Hata; Richard L Gallo Journal: J Invest Dermatol Date: 2016-07-02 Impact factor: 8.551