Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)

NCT00920621 | Completed Phase 3 Results DMC

• 3 other identifiers: 6555U01HL091528-03HL091528-01A1
• Study Type: interventional
• Target: 876
• Locations: 1 country
• Sites: 3

Brief Summary

Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children.

Conditions

Asthma

Keywords

Asthma; Vitamin D; Randomized Control Trial

Outcome Measures

Primary Outcomes (2)

• Asthma or Recurrent Wheeze in First 3 Years of Life

  Parental report of physician diagnosis of asthma or occurrence of recurrent wheeze in the child's first 3 years of life ascertained from questionnaires administered every 3 months. \*For some variables the "negative" count incorporates "negative and indeterminate."

  First 3 years of life.

• Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling.

  Maternal serum 25-hydroxyvitamin D measurement at third trimester during pregnancy

  32-38 weeks gestation

Secondary Outcomes (12)

• Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.

  3 years

• Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.

  1 year visit

• Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life.

  Child's first 3 years of life.

• Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life.

  Child's first 3 years of life.

• Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.

  Blood collection at childs' 3 year visit.

Study Arms (2)

Vitamin D treatment

EXPERIMENTAL

vitamin D treatment plus prenatal multivitamins

Dietary Supplement: Vitamin D 3 cholecalciferol; Dietary Supplement: Vitamin D3

placebo

PLACEBO COMPARATOR

placebo plus prenatal multivitamins

Dietary Supplement: Vitamin D3

Interventions

Vitamin D 3 cholecalciferol DIETARY_SUPPLEMENT

Dosage form oral Dosage 4000IU Vitamin D 3 cholecalciferol

Also known as: vitamin D, vitamin D3, cholecalciferol

Vitamin D treatment

Vitamin D3 DIETARY_SUPPLEMENT

4000 IU of vitamin D3 administered orally once a day during pregnancy

Vitamin D treatment; placebo

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Personal history of asthma, eczema, allergic rhinitis or a history of asthma, eczema, allergic rhinitis in the biological father of the child
• Gestational age between 10 and 18 weeks at the time of randomization
• Maternal age between 18 and 39 years
• Not a current smoker
• English or Spanish speaking
• Intent to participate for the full 4 years (through Pregnancy and then until the 3rd birthday of the child)

You may not qualify if:

• Gestational age greater than 18 weeks
• Presence of chronic medical conditions
• Taking vitamin D supplements containing more than 2000 IU/day of vitamin D3
• Multiple gestation pregnancy (twins, triplets)
• Pregnancy achieved by assisted reproduction techniques (e.g., IUI, IVF)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Robert Zeiger, MD

San Diego, California, United States

Location

George O'Connor, MD

Boston, Massachusetts, United States

Location

Leonard Bacharier, MD

St Louis, Missouri, United States

Location

Related Publications (25)

• Jung C, Lu Z, Litonjua AA, Loscalzo J, Weiss ST, Mirzakhani H. The association of early pregnancy vitamin D and BMI status with composite adverse pregnancy outcomes: an ancillary analysis of the Vitamin D Antenatal Asthma Reduction Trial. Am J Clin Nutr. 2025 Jul;122(1):324-334. doi: 10.1016/j.ajcnut.2025.04.034. Epub 2025 May 5.

  PMID: 40334749 DERIVED

• Kim M, Brustad N, Eliasen AU, Ali M, Wang T, Rasmussen MA, Ernst M, Hougaard D, Litonjua AA, Wheelock CE, Kelly RS, Chen Y, Prince N, Townsend PA, Stokholm J, Weiss ST, Bonnelykke K, Lasky-Su J, Chawes B. Bilirubin metabolism in early life and respiratory health during preschool age: A combined analysis of two independent birth cohorts. Med. 2024 Dec 13;5(12):1485-1494.e3. doi: 10.1016/j.medj.2024.07.021. Epub 2024 Aug 15.

  PMID: 39151420 DERIVED

• Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

  PMID: 39077939 DERIVED

• Kim M, Brustad N, Ali M, Gurdeniz G, Arendt M, Litonjua AA, Wheelock CE, Kelly RS, Chen Y, Prince N, Guo F, Zhou X, Stokholm J, Bonnelykke K, Weiss ST, Bisgaard H, Lasky-Su J, Chawes B. Maternal vitamin D-related metabolome and offspring risk of asthma outcomes. J Allergy Clin Immunol. 2023 Dec;152(6):1646-1657.e11. doi: 10.1016/j.jaci.2023.06.030. Epub 2023 Aug 8.

  PMID: 37558060 DERIVED

• Prince N, Kelly RS, Chu SH, Kachroo P, Chen Y, Mendez KM, Begum S, Bisgaard H, Bonnelykke K, Kim M, Levy O, Litonjua AA, Wheelock CE, Weiss ST, Chawes BL, Lasky-Su JA. Elevated third trimester corticosteroid levels are associated with fewer offspring infections. Sci Rep. 2023 Jun 28;13(1):10461. doi: 10.1038/s41598-023-36535-0.

  PMID: 37380711 DERIVED

• Knihtila HM, Huang M, Prince N, Stubbs BJ, Carey VJ, Laranjo N, Mirzakhani H, Zeiger RS, Bacharier LB, O'Connor GT, Litonjua AA, Weiss ST, Lasky-Su J. Maternal vitamin D status modifies the effects of early life tobacco exposure on child lung function. J Allergy Clin Immunol. 2023 Feb;151(2):556-564. doi: 10.1016/j.jaci.2022.10.030. Epub 2022 Nov 16.

  PMID: 36400177 DERIVED

• Lee-Sarwar KA, Chen YC, Chen YY, Kozyrskyj AL, Mandhane PJ, Turvey SE, Subbarao P, Bisgaard H, Stokholm J, Chawes B, Sorensen SJ, Kelly RS, Lasky-Su J, Zeiger RS, O'Connor GT, Sandel MT, Bacharier LB, Beigelman A, Carey VJ, Harshfield BJ, Laranjo N, Gold DR, Weiss ST, Litonjua AA. The maternal prenatal and offspring early-life gut microbiome of childhood asthma phenotypes. Allergy. 2023 Feb;78(2):418-428. doi: 10.1111/all.15516. Epub 2022 Sep 24.

  PMID: 36107703 DERIVED

• Knihtila HM, Kelly RS, Brustad N, Huang M, Kachroo P, Chawes BL, Stokholm J, Bonnelykke K, Pedersen CT, Bisgaard H, Litonjua AA, Lasky-Su JA, Weiss ST. Maternal 17q21 genotype influences prenatal vitamin D effects on offspring asthma/recurrent wheeze. Eur Respir J. 2021 Sep 23;58(3):2002012. doi: 10.1183/13993003.02012-2020. Print 2021 Sep.

  PMID: 33653805 DERIVED

• Litonjua AA, Carey VJ, Laranjo N, Stubbs BJ, Mirzakhani H, O'Connor GT, Sandel M, Beigelman A, Bacharier LB, Zeiger RS, Schatz M, Hollis BW, Weiss ST. Six-Year Follow-up of a Trial of Antenatal Vitamin D for Asthma Reduction. N Engl J Med. 2020 Feb 6;382(6):525-533. doi: 10.1056/NEJMoa1906137.

  PMID: 32023372 DERIVED

• Lu M, Hollis BW, Carey VJ, Laranjo N, Singh RJ, Weiss ST, Litonjua AA. Determinants and Measurement of Neonatal Vitamin D: Overestimation of 25(OH)D in Cord Blood Using CLIA Assay Technology. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1085-92. doi: 10.1210/clinem/dgz299.

  PMID: 31872219 DERIVED

• Lee-Sarwar KA, Kelly RS, Lasky-Su J, Zeiger RS, O'Connor GT, Sandel MT, Bacharier LB, Beigelman A, Rifas-Shiman SL, Carey VJ, Harshfield BJ, Laranjo N, Gold DR, Weiss ST, Litonjua AA. Fecal short-chain fatty acids in pregnancy and offspring asthma and allergic outcomes. J Allergy Clin Immunol Pract. 2020 Mar;8(3):1100-1102.e13. doi: 10.1016/j.jaip.2019.08.036. Epub 2019 Sep 5. No abstract available.

  PMID: 31494295 DERIVED

• Yu B, Zanetti KA, Temprosa M, Albanes D, Appel N, Barrera CB, Ben-Shlomo Y, Boerwinkle E, Casas JP, Clish C, Dale C, Dehghan A, Derkach A, Eliassen AH, Elliott P, Fahy E, Gieger C, Gunter MJ, Harada S, Harris T, Herr DR, Herrington D, Hirschhorn JN, Hoover E, Hsing AW, Johansson M, Kelly RS, Khoo CM, Kivimaki M, Kristal BS, Langenberg C, Lasky-Su J, Lawlor DA, Lotta LA, Mangino M, Le Marchand L, Mathe E, Matthews CE, Menni C, Mucci LA, Murphy R, Oresic M, Orwoll E, Ose J, Pereira AC, Playdon MC, Poston L, Price J, Qi Q, Rexrode K, Risch A, Sampson J, Seow WJ, Sesso HD, Shah SH, Shu XO, Smith GCS, Sovio U, Stevens VL, Stolzenberg-Solomon R, Takebayashi T, Tillin T, Travis R, Tzoulaki I, Ulrich CM, Vasan RS, Verma M, Wang Y, Wareham NJ, Wong A, Younes N, Zhao H, Zheng W, Moore SC. The Consortium of Metabolomics Studies (COMETS): Metabolomics in 47 Prospective Cohort Studies. Am J Epidemiol. 2019 Jun 1;188(6):991-1012. doi: 10.1093/aje/kwz028.

  PMID: 31155658 DERIVED

• Lee-Sarwar KA, Kelly RS, Lasky-Su J, Zeiger RS, O'Connor GT, Sandel MT, Bacharier LB, Beigelman A, Laranjo N, Gold DR, Weiss ST, Litonjua AA. Integrative analysis of the intestinal metabolome of childhood asthma. J Allergy Clin Immunol. 2019 Aug;144(2):442-454. doi: 10.1016/j.jaci.2019.02.032. Epub 2019 Mar 23.

  PMID: 30914378 DERIVED

• Mirzakhani H, Carey VJ, Zeiger R, Bacharier LB, O'Connor GT, Schatz MX, Laranjo N, Weiss ST, Litonjua AA. Impact of parental asthma, prenatal maternal asthma control, and vitamin D status on risk of asthma and recurrent wheeze in 3-year-old children. Clin Exp Allergy. 2019 Apr;49(4):419-429. doi: 10.1111/cea.13320. Epub 2019 Jan 3.

  PMID: 30461089 DERIVED

• Savage JH, Lee-Sarwar KA, Sordillo JE, Lange NE, Zhou Y, O'Connor GT, Sandel M, Bacharier LB, Zeiger R, Sodergren E, Weinstock GM, Gold DR, Weiss ST, Litonjua AA. Diet during Pregnancy and Infancy and the Infant Intestinal Microbiome. J Pediatr. 2018 Dec;203:47-54.e4. doi: 10.1016/j.jpeds.2018.07.066. Epub 2018 Aug 30.

  PMID: 30173873 DERIVED

• Mirzakhani H, Carey VJ, McElrath TF, Qiu W, Hollis BW, O'Connor GT, Zeiger RS, Bacharier L, Litonjua AA, Weiss ST. Impact of Preeclampsia on the Relationship between Maternal Asthma and Offspring Asthma. An Observation from the VDAART Clinical Trial. Am J Respir Crit Care Med. 2019 Jan 1;199(1):32-42. doi: 10.1164/rccm.201804-0770OC.

  PMID: 30153046 DERIVED

• Mirzakhani H, Al-Garawi AA, Carey VJ, Qiu W, Litonjua AA, Weiss ST. Expression network analysis reveals cord blood vitamin D-associated genes affecting risk of early life wheeze. Thorax. 2019 Feb;74(2):200-202. doi: 10.1136/thoraxjnl-2018-211962. Epub 2018 Jul 18.

  PMID: 30021811 DERIVED

• Kelly RS, Sordillo JE, Lasky-Su J, Dahlin A, Perng W, Rifas-Shiman SL, Weiss ST, Gold DR, Litonjua AA, Hivert MF, Oken E, Wu AC. Plasma metabolite profiles in children with current asthma. Clin Exp Allergy. 2018 Oct;48(10):1297-1304. doi: 10.1111/cea.13183. Epub 2018 Jul 3.

  PMID: 29808611 DERIVED

• Wolsk HM, Chawes BL, Litonjua AA, Hollis BW, Waage J, Stokholm J, Bonnelykke K, Bisgaard H, Weiss ST. Prenatal vitamin D supplementation reduces risk of asthma/recurrent wheeze in early childhood: A combined analysis of two randomized controlled trials. PLoS One. 2017 Oct 27;12(10):e0186657. doi: 10.1371/journal.pone.0186657. eCollection 2017.

  PMID: 29077711 DERIVED

• Blighe K, Chawes BL, Kelly RS, Mirzakhani H, McGeachie M, Litonjua AA, Weiss ST, Lasky-Su JA. Vitamin D prenatal programming of childhood metabolomics profiles at age 3 y. Am J Clin Nutr. 2017 Oct;106(4):1092-1099. doi: 10.3945/ajcn.117.158220. Epub 2017 Aug 23.

  PMID: 28835366 DERIVED

• Mirzakhani H, O'Connor G, Bacharier LB, Zeiger RS, Schatz MX, Weiss ST, Litonjua AA. Asthma control status in pregnancy, body mass index, and maternal vitamin D levels. J Allergy Clin Immunol. 2017 Nov;140(5):1453-1456.e7. doi: 10.1016/j.jaci.2017.03.053. Epub 2017 Jun 9.

  PMID: 28606587 DERIVED

• Hornsby E, Pfeffer PE, Laranjo N, Cruikshank W, Tuzova M, Litonjua AA, Weiss ST, Carey VJ, O'Connor G, Hawrylowicz C. Vitamin D supplementation during pregnancy: Effect on the neonatal immune system in a randomized controlled trial. J Allergy Clin Immunol. 2018 Jan;141(1):269-278.e1. doi: 10.1016/j.jaci.2017.02.039. Epub 2017 May 26.

  PMID: 28552588 DERIVED

• Mirzakhani H, Litonjua AA, McElrath TF, O'Connor G, Lee-Parritz A, Iverson R, Macones G, Strunk RC, Bacharier LB, Zeiger R, Hollis BW, Handy DE, Sharma A, Laranjo N, Carey V, Qiu W, Santolini M, Liu S, Chhabra D, Enquobahrie DA, Williams MA, Loscalzo J, Weiss ST. Early pregnancy vitamin D status and risk of preeclampsia. J Clin Invest. 2016 Dec 1;126(12):4702-4715. doi: 10.1172/JCI89031. Epub 2016 Nov 14.

  PMID: 27841759 DERIVED

• Al-Garawi A, Carey VJ, Chhabra D, Mirzakhani H, Morrow J, Lasky-Su J, Qiu W, Laranjo N, Litonjua AA, Weiss ST. The Role of Vitamin D in the Transcriptional Program of Human Pregnancy. PLoS One. 2016 Oct 6;11(10):e0163832. doi: 10.1371/journal.pone.0163832. eCollection 2016.

  PMID: 27711190 DERIVED

• Litonjua AA, Carey VJ, Laranjo N, Harshfield BJ, McElrath TF, O'Connor GT, Sandel M, Iverson RE Jr, Lee-Paritz A, Strunk RC, Bacharier LB, Macones GA, Zeiger RS, Schatz M, Hollis BW, Hornsby E, Hawrylowicz C, Wu AC, Weiss ST. 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. doi: 10.1001/jama.2015.18589.

  PMID: 26813209 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Scott T. Weiss, MD, MS
• Organization: Brigham and Women's Hospital

scott.weiss@channing.harvard.edu

617-525-2278

Study Officials

• Scott T Weiss

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 15, 2009
• Study Start: September 1, 2009
• Primary Completion: January 21, 2015
• Study Completion: August 1, 2023
• Last Updated: May 12, 2026
• Results First Posted: July 14, 2017

Record last verified: 2026-04

Locations

US (3)