NCT00856947

Brief Summary

The aim of this study is to prevent asthma symptoms (recurrent wheeze) in childhood by supplementation with high dose vitamin D to the mother during pregnancy. Participants are mothers and children of the ABC (Asthma Begins in Childhood) cohort. Mothers are recruited during pregnancy and receive daily supplement with 2400 IU of Vitamin D3 or placebo from week 24 og gestation to 1 week after delivery. In addition all mothers are advised to take the recommended dose of 400 IU vitamin D daily. The mothers in ABC also participate in an interventional trial with fish oil supplementation, and the vitamin D randomization is stratified by fish oil treatment group. The child is followed with acute and planned vits at the research unit, and wheeze is diagnosed according to predefined algorithms.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_1 asthma

Timeline
14mo left

Started Mar 2009

Longer than P75 for phase_1 asthma

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2009Jul 2027

Study Start

First participant enrolled

March 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
18.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

18.3 years

First QC Date

March 4, 2009

Last Update Submit

March 17, 2026

Conditions

Asthma

Keywords

wheezeinfectionsallergyeczemavitamin D

Outcome Measures

Primary Outcomes (1)

  • Persistent wheeze

    Age at onset of persistent wheeze diagnosed according to predefined algorithm of recurrent troublesome lung symptoms, response to treatment and relapse after withdrawal of treatment

    0 to 3 years of age

Secondary Outcomes (12)

  • Infections

    0 to 3 years of age

  • Allergic sensitization

    6 and 18 months of age

  • Eczema

    0 to 3 years of age

  • Mothers levels of 25-OH-Vitamin D, PTH, Calcium, alkaline phosphatase

    1 week after delivery

  • Growth

    0 to 3 years of age

  • +7 more secondary outcomes

Other Outcomes (24)

  • Asthma

    3-10 years of age

  • Lung function measurements

    5-10 years of age

  • Infections

    3-10 years of age

  • +21 more other outcomes

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Dietary supplement: 2400 IU Vitamin D3 (2 tablets of 1200 IU) from week 24 of gestation to 1 week after delivery

Dietary Supplement: Cholecalciferol D3

Placebo

PLACEBO COMPARATOR

Placebo: 2 placebo tablets with no active substance, identical to the active tablets, from week 24 of gestation to 1 week after delivery

Other: Placebo tablet

Interventions

Cholecalciferol D3DIETARY_SUPPLEMENT

2 tablets of 1200 IU daily from week 24 of gestation to 1 week after delivery

Also known as: Vitamin D from Camette, Denmark
Vitamin D
Placebo tabletOTHER

2 tablets containing no active substance

Also known as: Placebo tablets from Camette, Denmark
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mother:
  • Pregnant in week 22-26 of gestation
  • Participating in the ABC-cohort
  • Living in Sealand, Denmark
  • Fluent in Danish
  • Willing to let the child participate in the study

You may not qualify if:

  • Mother:
  • Intake of more than 400 IU of vitamin D during the last 6 months
  • Endocrinological disease such as calcium metabolic disorder, parathyroid disorder, thyroid disorder or Diabetes type 1
  • Tuberculosis
  • Sarcoidosis
  • In need of diuretics or heart medication including calcium channel blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Copenhagen University Hospital of Copenhagen

Gentofte Municipality, Gentofte, 2820, Denmark

Location

Næstved Hospital, Pediatric Department

Næstved, Næstved, 4700, Denmark

Location

Related Publications (10)

  • 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: 39077939DERIVED

  • Aagaard K, Mollegaard Jepsen JR, Sevelsted A, Horner D, Vinding R, Rosenberg JB, Brustad N, Eliasen A, Mohammadzadeh P, Folsgaard N, Hernandez-Lorca M, Fagerlund B, Glenthoj BY, Rasmussen MA, Bilenberg N, Stokholm J, Bonnelykke K, Ebdrup BH, Chawes B. High-dose vitamin D3 supplementation in pregnancy and risk of neurodevelopmental disorders in the children at age 10: A randomized clinical trial. Am J Clin Nutr. 2024 Feb;119(2):362-370. doi: 10.1016/j.ajcnut.2023.12.002. Epub 2023 Dec 9.

    PMID: 38072183DERIVED

  • Brustad N, Yang L, Chawes BL, Stokholm J, Gurdeniz G, Bonnelykke K, Bisgaard H. Fish Oil and Vitamin D Supplementations in Pregnancy Protect Against Childhood Croup. J Allergy Clin Immunol Pract. 2023 Jan;11(1):315-321. doi: 10.1016/j.jaip.2022.09.027. Epub 2022 Sep 30.

    PMID: 36184023DERIVED

  • Mohammadzadeh P, Rosenberg JB, Vinding R, Mollegaard Jepsen JR, Lindberg U, Folsgaard N, Erlang Sorensen M, Sulaiman D, Bilenberg N, Mitta Raghava J, Fagerlund B, Vestergaard M, Pantelis C, Stokholm J, Chawes B, Larsson H, Glenthoj BY, Bonnelykke K, Ebdrup BH, Bisgaard H. Effects of prenatal nutrient supplementation and early life exposures on neurodevelopment at age 10: a randomised controlled trial - the COPSYCH study protocol. BMJ Open. 2022 Feb 1;12(2):e047706. doi: 10.1136/bmjopen-2020-047706.

    PMID: 35105560DERIVED

  • 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: 33653805DERIVED

  • Sass L, Vinding RK, Stokholm J, Bjarnadottir E, Noergaard S, Thorsen J, Sunde RB, McGrath J, Bonnelykke K, Chawes B, Bisgaard H. High-Dose Vitamin D Supplementation in Pregnancy and Neurodevelopment in Childhood: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2026018. doi: 10.1001/jamanetworkopen.2020.26018.

    PMID: 33289844DERIVED

  • Brustad N, Garland J, Thorsen J, Sevelsted A, Krakauer M, Vinding RK, Stokholm J, Bonnelykke K, Bisgaard H, Chawes BL. Effect of High-Dose vs Standard-Dose Vitamin D Supplementation in Pregnancy on Bone Mineralization in Offspring Until Age 6 Years: A Prespecified Secondary Analysis of a Double-Blinded, Randomized Clinical Trial. JAMA Pediatr. 2020 May 1;174(5):419-427. doi: 10.1001/jamapediatrics.2019.6083.

    PMID: 32091548DERIVED

  • Norrisgaard PE, Haubek D, Kuhnisch J, Chawes BL, Stokholm J, Bonnelykke K, Bisgaard H. Association of High-Dose Vitamin D Supplementation During Pregnancy With the Risk of Enamel Defects in Offspring: A 6-Year Follow-up of a Randomized Clinical Trial. JAMA Pediatr. 2019 Oct 1;173(10):924-930. doi: 10.1001/jamapediatrics.2019.2545.

    PMID: 31381020DERIVED

  • 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: 29077711DERIVED

  • Chawes BL, Bonnelykke K, Stokholm J, Vissing NH, Bjarnadottir E, Schoos AM, Wolsk HM, Pedersen TM, Vinding RK, Thorsteinsdottir S, Arianto L, Hallas HW, Heickendorff L, Brix S, Rasmussen MA, Bisgaard H. Effect of Vitamin D3 Supplementation During Pregnancy on Risk of Persistent Wheeze in the Offspring: A Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):353-61. doi: 10.1001/jama.2015.18318.

    PMID: 26813208DERIVED

MeSH Terms

Conditions

AsthmaRespiratory SoundsInfectionsHypersensitivityEczema

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Klaus Bønnelykke, MD, PhD

    Copenhagen Studies on Asthma in Childhood

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 6, 2009

Study Start

March 1, 2009

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

DK(2)