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Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial.
JAMA. 2016 Jan 26; 315(4):362-70.JAMA

Abstract

IMPORTANCE

Asthma and wheezing begin early in life, and prenatal vitamin D deficiency has been variably associated with these disorders in offspring.

OBJECTIVE

To determine whether prenatal vitamin D (cholecalciferol) supplementation can prevent asthma or recurrent wheeze in early childhood.

DESIGN, SETTING, AND PARTICIPANTS

The Vitamin D Antenatal Asthma Reduction Trial was a randomized, double-blind, placebo-controlled trial conducted in 3 centers across the United States. Enrollment began in October 2009 and completed follow-up in January 2015. Eight hundred eighty-one pregnant women between the ages of 18 and 39 years at high risk of having children with asthma were randomized at 10 to 18 weeks' gestation. Five participants were deemed ineligible shortly after randomization and were discontinued.

INTERVENTIONS

Four hundred forty women were randomized to receive daily 4000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D, and 436 women were randomized to receive a placebo plus a prenatal vitamin containing 400 IU vitamin D.

MAIN OUTCOMES AND MEASURES

Coprimary outcomes of (1) parental report of physician-diagnosed asthma or recurrent wheezing through 3 years of age and (2) third trimester maternal 25-hydroxyvitamin D levels.

RESULTS

Eight hundred ten infants were born in the study, and 806 were included in the analyses for the 3-year outcomes. Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%-28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%-73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6-1.0; P = .051). Of the women in the 4400-IU group whose blood levels were checked, 289 (74.9%) had 25-hydroxyvitamin D levels of 30 ng/mL or higher by the third trimester of pregnancy compared with 133 of 391 (34.0%) in the 400-IU group (difference, 40.9%; 95% CI, 34.2%-47.5%, P < .001).

CONCLUSIONS AND RELEVANCE

In pregnant women at risk of having a child with asthma, supplementation with 4400 IU/d of vitamin D compared with 400 IU/d significantly increased vitamin D levels in the women. The incidence of asthma and recurrent wheezing in their children at age 3 years was lower by 6.1%, but this did not meet statistical significance; however, the study may have been underpowered. Longer follow-up of the children is ongoing to determine whether the difference is clinically important.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00920621.

Authors+Show Affiliations

Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts.Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts.Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.Harvard Medical School, Boston, Massachusetts3Department of Obstetrics and Gynecology, Brigham & Women's Hospital, Boston, Massachusetts.Pulmonary Center, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts.Department of Pediatrics, Boston Medical Center, Boston, Massachusetts.Department of Obstetrics and Gynecology, Boston Medical Center, Boston, Massachusetts.Department of Obstetrics and Gynecology, Boston Medical Center, Boston, Massachusetts.Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St Louis, Missouri8St Louis Children's Hospital, St Louis, Missouri.Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St Louis, Missouri8St Louis Children's Hospital, St Louis, Missouri.Department of Obstetrics and Gynecology, Washington University School of Medicine, St Louis, Missouri.Kaiser Permanente Southern California, San Diego, California.Kaiser Permanente Southern California, San Diego, California.Department of Pediatrics, Medical University of South Carolina, Charleston.King's College London School of Medicine, Asthma, Allergy and Respiratory Science, Guy's Hospital Campus, London, United Kingdom.King's College London School of Medicine, Asthma, Allergy and Respiratory Science, Guy's Hospital Campus, London, United Kingdom.Harvard Medical School, Boston, Massachusetts13Department of Population Medicine, Harvard Pilgrim Health Care Institute and Children's Hospital Boston, Boston, Massachusetts.Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26813209

Citation

Litonjua, Augusto A., et al. "Effect of Prenatal Supplementation With Vitamin D On Asthma or Recurrent Wheezing in Offspring By Age 3 Years: the VDAART Randomized Clinical Trial." JAMA, vol. 315, no. 4, 2016, pp. 362-70.
Litonjua AA, Carey VJ, Laranjo N, et al. Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial. JAMA. 2016;315(4):362-70.
Litonjua, A. A., Carey, V. J., Laranjo, N., Harshfield, B. J., McElrath, T. F., O'Connor, G. T., Sandel, M., Iverson, R. E., Lee-Paritz, A., Strunk, R. C., Bacharier, L. B., Macones, G. A., Zeiger, R. S., Schatz, M., Hollis, B. W., Hornsby, E., Hawrylowicz, C., Wu, A. C., & Weiss, S. T. (2016). Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial. JAMA, 315(4), 362-70. https://doi.org/10.1001/jama.2015.18589
Litonjua AA, et al. Effect of Prenatal Supplementation With Vitamin D On Asthma or Recurrent Wheezing in Offspring By Age 3 Years: the VDAART Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):362-70. PubMed PMID: 26813209.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial. AU - Litonjua,Augusto A, AU - Carey,Vincent J, AU - Laranjo,Nancy, AU - Harshfield,Benjamin J, AU - McElrath,Thomas F, AU - O'Connor,George T, AU - Sandel,Megan, AU - Iverson,Ronald E,Jr AU - Lee-Paritz,Aviva, AU - Strunk,Robert C, AU - Bacharier,Leonard B, AU - Macones,George A, AU - Zeiger,Robert S, AU - Schatz,Michael, AU - Hollis,Bruce W, AU - Hornsby,Eve, AU - Hawrylowicz,Catherine, AU - Wu,Ann Chen, AU - Weiss,Scott T, PY - 2016/1/28/entrez PY - 2016/1/28/pubmed PY - 2016/2/5/medline SP - 362 EP - 70 JF - JAMA JO - JAMA VL - 315 IS - 4 N2 - IMPORTANCE: Asthma and wheezing begin early in life, and prenatal vitamin D deficiency has been variably associated with these disorders in offspring. OBJECTIVE: To determine whether prenatal vitamin D (cholecalciferol) supplementation can prevent asthma or recurrent wheeze in early childhood. DESIGN, SETTING, AND PARTICIPANTS: The Vitamin D Antenatal Asthma Reduction Trial was a randomized, double-blind, placebo-controlled trial conducted in 3 centers across the United States. Enrollment began in October 2009 and completed follow-up in January 2015. Eight hundred eighty-one pregnant women between the ages of 18 and 39 years at high risk of having children with asthma were randomized at 10 to 18 weeks' gestation. Five participants were deemed ineligible shortly after randomization and were discontinued. INTERVENTIONS: Four hundred forty women were randomized to receive daily 4000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D, and 436 women were randomized to receive a placebo plus a prenatal vitamin containing 400 IU vitamin D. MAIN OUTCOMES AND MEASURES: Coprimary outcomes of (1) parental report of physician-diagnosed asthma or recurrent wheezing through 3 years of age and (2) third trimester maternal 25-hydroxyvitamin D levels. RESULTS: Eight hundred ten infants were born in the study, and 806 were included in the analyses for the 3-year outcomes. Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%-28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%-73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6-1.0; P = .051). Of the women in the 4400-IU group whose blood levels were checked, 289 (74.9%) had 25-hydroxyvitamin D levels of 30 ng/mL or higher by the third trimester of pregnancy compared with 133 of 391 (34.0%) in the 400-IU group (difference, 40.9%; 95% CI, 34.2%-47.5%, P < .001). CONCLUSIONS AND RELEVANCE: In pregnant women at risk of having a child with asthma, supplementation with 4400 IU/d of vitamin D compared with 400 IU/d significantly increased vitamin D levels in the women. The incidence of asthma and recurrent wheezing in their children at age 3 years was lower by 6.1%, but this did not meet statistical significance; however, the study may have been underpowered. Longer follow-up of the children is ongoing to determine whether the difference is clinically important. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00920621. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/26813209/Effect_of_Prenatal_Supplementation_With_Vitamin_D_on_Asthma_or_Recurrent_Wheezing_in_Offspring_by_Age_3_Years:_The_VDAART_Randomized_Clinical_Trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2015.18589 DB - PRIME DP - Unbound Medicine ER -