Received: 3 November 2020 | Revised: 18 December 2020 | Accepted: 18 January 2021

DOI: 10.1002/ppul.25287

ORIGINAL ARTICLE: ASTHMA

Vitamin‐D supplementation as an adjunct to standard treatment

of asthma in children: A randomized controlled trial
(ViDASTA Trial)

Chirag Thakur MD1 | Jogender Kumar DM2 | Prawin Kumar MD1 |

Jagdish Prasad Goyal MD1 | Kuldeep Singh DM1 | Atul Gupta FRCPH3

1
Department of Pediatrics, All India Institute of
Medical Sciences, Jodhpur, Rajasthan, India
2
Department of Pediatrics, Post Graduate
Institute of Medical Education and Research,
Chandigarh, India
3
Department of Pediatric Respiratory
Medicine, King's College Hospital, Institute for
Women's and Children's Health, London, UK
Correspondence
Jagdish Prasad Goyal, MD, Department of
Pediatrics, Room No. 41, 2nd Floor, Admin
Block; All India Institute of Medical Sciences,
Jodhpur, Rajasthan 342005, India.
Email: jpgoyal@rediffmail.com and
goyal.drjagdish@gmail.com
Abstract
Objective: To determine the role of vitamin D supplementation as an adjunct to
standard treatment in childhood asthma.
Study Design: In this placebo‐controlled, blinded, randomized controlled trial, we en-
rolled 60 children aged 6 to 11 years with moderate persistent asthma and randomly
assigned them into intervention (2000 IU per day of vitamin D) and placebo groups
(n = 30 each). The primary outcome was asthma control as assessed by the childhood
asthma control test (C‐ACT) scores at 12 weeks post‐randomization. The secondary
outcomes were improvement in the forced expiration in 1 s (FEV1), fractional exhaled
nitric oxide (FeNO), asthma exacerbations, use of systemic steroids, number of emer-
gency visits, post‐intervention vitamin D levels, and adverse outcomes. We analyzed by
intention to treat.
Results: There was no significant difference between the C‐ACT score in the two
groups (median [first–third quartile] scores were 25 [24–26] in both groups, p = 0.7).
Also, there was no significant difference between the two groups in terms of the
FEV1, FeNO, number of exacerbations, emergency visits, hospital admissions, and
adverse outcomes. However, the post‐intervention vitamin D levels (ng/ml) were
significantly higher in the intervention group (35.5 vs. 18.8; p < 0.001). As compared
to the baseline, both the groups showed better asthma control at 12 weeks post‐
intervention, irrespective of the type of intervention.
Conclusion: Vitamin‐D supplementation as an adjunct to standard treatment does
not improve asthma control in children.

KEYWORDS

asthma, childhood asthma control test, children, FeNO, spirometry, vitamin D

1 | INTRODUCTION vitamin D levels. Vitamin D deficiency is associated with increased

Vitamin D plays a role in the pathogenesis of asthma by its effects on
1
the innate and adaptive immune system. Emerging evidence suggests a
positive relationship between childhood asthma control and serum
airway hyper‐responsiveness, lower pulmonary functions, poor asthma
control, and possibly steroid resistance.2 Various observational studies
suggested an association of vitamin‐D deficiency and increased risk for
childhood asthma and allergies.3–6 A recent systemic review showed

Abbreviations: C‐ACT, childhood asthma control test; FDC, fixed‐dose combination; FeNO, fractional exhaled nitric oxide; FEV1, forced expiration in 1 s; ICS, inhaled corticosteroids.

Pediatric Pulmonology. 2021;1–7. wileyonlinelibrary.com/journal/ppul © 2021 Wiley Periodicals LLC | 1

2 |
that asthmatic children have lower serum vitamin D levels compared to
controls.7 There is low‐quality evidence to support the routine vitamin
D supplementation for the reduction of asthma exacerbations in chil-
dren.8 However, there is uncertainty about whether vitamin D supple-
mentation during childhood improves other asthma‐related outcomes
(hospital admissions, pulmonary function tests, etc.) and warrants fur-
ther exploration in well‐designed randomized controlled trials. We hy-
pothesized that vitamin D supplementation, in addition to the standard
treatment of asthma among asthmatic children between 6 and 11 years,
would result in better asthma control, lesser exacerbations and hospital
admissions, and better pulmonary functions. Therefore, we planned a
randomized control trial to determine whether vitamin D supple-
mentation as an adjunct to the standard treatment of asthma in children
achieves better asthma control than placebo.
2 | METHODS
We conducted a randomized, blinded, parallel‐group, placebo‐
controlled trial at a tertiary care hospital in Western India from July
2018 to November 2019. The institute's ethics committee approved
the study protocol. The study was registered in the Clinical Trials
Registry–India (identifier CTRI/2018/07/014777). Children aged 6 to
11 years with first time diagnosed asthma in clinic were screened for
eligibility. Those with moderate persistent asthma (Step 3 GINA) and
willing to take prescribed medication and monthly follow‐up for at
least 3 months were enrolled. We excluded children with rickets,
bronchopulmonary dysplasia, coexisting primary parenchymal pul-
monary disease (e.g., cystic fibrosis), congenital or acquired heart
diseases, renal or hepatic insufficiency, on antiepileptic drugs, known
case of vitamin‐D deficiency or parathyroid disease, and those re-
ceived vitamin D or calcium supplements in past 3 months. It was
ensured that the family was willing to take medication for 3 months
and regular follow‐up. We enrolled eligible children after obtaining
written informed consent from a parent and assent from the children.
We allocated subjects by a block randomization design generated
using the www.randomizer.com website. One of the investigators (J.K.)
generated the randomization sequence and constructed randomly vary-
ing, permuted, even‐numbered blocks for each stratum. He concealed the
block sizes until the end of the study and was not involved in subject
recruitment. We ensured concealment of allocation using serially num-
bered, opaque, sealed envelopes that contained a slip of paper with the
allocation group. The drug and placebo were manufactured and supplied
by M/s Mankind Pharma Ltd., India, in tablet form, packed as 2000 IU per
tablet. The company did not have any role in study design, funding, data
collection, or analysis and the data was not shared with them. The drugs
and placebo were packaged identically in strips of 10 tablets and were
similar in appearance, taste, and smell. The placebo contained identical
components to those in the active treatment group, except for chole-
calciferol. Both drug and placebo were coded and stored in a cool, dry,
and dark place till dispensed. The patients, primary investigator, clinician,
and laboratory personal were blinded to the intervention. The drug
coding was opened at the end of the final analysis.
THAKUR ET AL.
The first investigator (C.T.) enrolled subjects and allocated them to
the intervention and control arms. Baseline clinical details were recorded
in pre‐structured proforma. Spirometry and fractional exhaled nitric oxide
(FeNO) were done in all enrolled participants by a trained person (not
part of the study) at enrollment (baseline) and was repeated at 3 months
(follow‐up). Spirometry was performed following American Thoracic So-
ciety recommendations (ATS)/European Respiratory Society (ERS) re-
commendations and the best forced expiratory volume in 1 s (FEV1) was
recorded.9 The FeNO was determined by using a NIOX Mino (Aerocrine
AB, Stockholm, Sweden) as per ATS/ERS recommendations.10 Three‐
milliliter venous blood sample was obtained in a serum separator vacu-
tainer at enrollment (baseline) and 3 months after enrollment (post‐
intervention). The sample was immediately transported to the laboratory
in an ice‐box and serum was separated, labeled, and stored at –20°C in a
deep refrigerator. Serum 25(OH)D levels were estimated by chemilumi-
nescence technology (CLIA) using a commercially available kit (LIAISON).
Children were provided 30 tablets for a month and were in-
structed to submit an empty strip with the asthma clinic nurse and
were issued 30 more tablets from the same batch number. We
treated subjects in both the groups as per the GINA guideline which
consists of budesonide 400 μg and formoterol 24 μg daily (Step 3).
This is a fixed‐dose combination, one puff contained 100 μg bude-
sonide and 6 μg formoterol. The participants had taken two puffs
morning and two puffs evening. All participants were advised to take
short‐acting β‐agonist in case of an asthma exacerbation.
Asthma symptoms diary was given to the participants to record
symptoms such as cough, breathlessness, sleep disturbance, school
absent due to asthma, and use of rescue medicine daily. The parti-
cipants visited the asthma clinic at a monthly interval till 3 months
post enrollment and each time their symptom diary and empty strips
were checked. They were thoroughly examined and evaluated for the
pre‐defined clinical and laboratory parameters. The drug or placebo
was dispensed every month. Compliance with treatment was as-
sessed by an empty strip of tablets. Children missing more than 20%
of the medication were considered noncompliant. All empty strips
were preserved until the end of the study. On each visit compliance
with inhaled corticosteroids (ICS) and technique was also evaluated.
Asthma control was assessed by GINA asthma control and childhood
asthma control test (C‐ACT) score on each visit.
2.1 | Outcomes
The primary outcome was an improvement in the C‐ACT score from
baseline to the end of the study period (3 months). The C‐ACT is a
validated score11 and calculated based on seven questions (Three an-
swered by the parent and four answered with the child's input) and has a
score range of 0 to 27. The higher scores indicate better symptom
control, and a score greater than 19 indicates well‐controlled asthma
symptoms. Secondary outcomes included improvement in the spirometry
parameters like FEV1 and FeNO, number of asthma exacerbations, use of
systemic steroids, and number of emergency visits, number of hospitali-
zations, vitamin D3 levels at 3 months, and adverse outcomes.
THAKUR ET AL.
2.2 | Safety
All recruited patients were assessed for clinical evidence of vitamin D
intoxication at every visit. Symptoms of hypervitaminosis such as dehy-
dration, vomiting, decreased appetite (anorexia), irritability, constipation,
fatigue, abdominal cramps, muscle weakness, and polyuria were enquired.
Blood pressure was measured on each visit. Adverse events (solicited and
unsolicited) were monitored throughout the study in a symptom diary.
2.3 | Sample size
Our study had a fixed follow‐up period of 3 months. At the 5% sig-
nificance level, a total of 28 patients per group is required to achieve
80% power and to determine an increase of three points in the C‐ACT
score between the intervention and the control group, assuming that
the standard deviation of the groups is equal to 4.12 Taking into account
10% attrition, the final sample size was rounded to 30 in each group.
2.4 | Statistical analysis
We described categorical variables as percentages, normally distributed
numerical variables as means (with SDs), and those with skewed dis-
tributions as medians (first and third quartiles). We determined skewness
by using the Shapiro–Wilk test and the Q–Q plot. We compared cate-
gorical outcome variables by using the χ2 test or Fisher's exact test as
FIGURE 1 Flow of participants in the trial
| 3
appropriate. We compared numerical variables by using the Student's
t test or Mann–Whitney U test as applicable. As the primary outcome
was different at baseline itself, we used analysis of covariance (ANCOVA)
to adjust for covariates. We used SPSS version 23 (IBM SPSS Statistics;
IBM Corporation) for statistical analysis. A p value of less than 0.05 was
considered statistically significant. We analyzed by intention to treat.
3 | RE SU LTS
A total of 110 children were screened for eligibility, and 60 were enrolled
(30 each in vitamin D supplementation and placebo group). Two parti-
cipants in each group lost to follow‐up due to various reasons (Figure 1),
and the primary outcome was available for 56 children (28 in each group).
However, as decided a priori, we did intention to treat analysis, and all 60
children were analyzed for the primary outcome. The baseline char-
acteristics except for C‐ACT scores were similar across groups (Table 1).
The baseline C‐ACT score was significantly higher in the intervention
group (p = 0.001); however, the mean score was less than 19 in both
groups, suggesting poorly controlled asthma at the enrollment.
At the end of the study period, there was no significant difference
between the C‐ACT score in the two groups (median [first–third quartile]
scores were 25 [24–26] in both groups, p = 0.719) (Figure 2). Due to
significantly different baseline scores, we did a univariate ANCOVA to
determine a statistically significant difference between the vitamin D3
and the control group on the C‐ACT score at 3 months while controlling
for the baseline C‐ACT score. There was no significant effect of vitamin D
4 | THAKUR ET AL.

supplementation over the severity of asthma, after controlling for base-

line severity, (F (1, 53) = 0.002; p = 0.96).
At 3‐month post‐intervention, the vitamin‐D levels were sig-
nificantly higher in the intervention group. (Mean [SD] levels [ng/ml]
were 35.5 [10] versus 18.8 [10]; mean difference, 16.69 (12.1–21.3);
p < 0.001) (Table 2). Five (17%) children (all in placebo) were deficient
(<12 ng/ml) (10, 11) at 3 months. There was no significant difference
between FEV1 and FeNO. Eleven (18%) children had exacerbations
(four in intervention, seven in the placebo group); however, none of
them required emergency visits or hospitalization. All the exacerba-
tions were mild and managed on an outpatient basis. There was no
significant difference between the two groups in terms of the number
of exacerbations, emergency visits, and hospital admissions. Out of
60 participants, 11 patients received systematic steroids (4 in in-
tervention and 7 in the placebo group; p‐0.3). F I G U R E 2 Effect of vitamin D supplement [Color figure can be
To compare the effect of asthma therapy during the study period, we viewed at wileyonlinelibrary.com]
used a student t‐test to compare various clinical and laboratory para-
meters at baseline and the end of the study period (Table 3). As expected, the FeNO improved significantly in the placebo group but not in the
vitamin D levels significantly improved at the end of the study in the vitamin D group. This may indicate that the children in the placebo group
intervention group (35.5 vs. 15.7, p < 0.001), but not in the placebo. The might have more eosinophilic inflammation that had responded well to
C‐ACT score and FEV1 improved significantly in both groups. However, ICS compared to the vitamin D group.

Parameter Vitamin D (n = 30) Placebo (n = 30) p Value

T A B L E 1 Baseline characteristics of the
study participants (n = 60)
Age (years) 0.5
Mean (SD) 9.0 (1.7) 8.7 (1.6)
Median (first−third quartile) 9 (7–11) 9 (7.7–11)

Male, n (%) 16 (53.4) 18 (60) 0.8

BMI Z‐scores −0.90 (−1.5 to −0.4) −0.83 (−1.4 0.7

to −0.3)

Median (first–third quartile), n (%)

Exclusive breast feeding till 6 months 16 (53.4) 20 (66.7) 0.4
of age
Family history of asthma 13 (43.4) 15 (50) 0.8
Rural residence 13 (43.4) 18 (60) 0.3
Frequent exposure to smoke/dust 25 (83.3) 26 (87.7) 1.0
Exposure to pets at home 16 (53.4) 17 (56.7) 1.0
Seasonal variation of symptoms 19 (63.3) 23 (76.7) 0.4

Drugs used for asthma before enrollment

Beta‐2 agonists 15 (50) 15 (50) 1.0
ICS 14 (46.7) 13 (43.3) 0.79
Systemic steroid 12 (40) 14 (46.6) 0.60
LTRA 27 (90) 25 (83.3) 0.44
Cough syrup 28 (93.3) 30 (100) 0.15
Homeopathy/ayurvedic 10 (33.3) 6 (20) 0.24
Baseline C‐ACT score mean (SD) 18 (2.9) 15.5 (2.7) 0.001

Vitamin D3 (ng/ml) 0.7

Mean (SD) 15.8 (8.2) 16.5 (9.9)
Median (first–third quartile) 14.4 (9.8–17.2) 16.3 (8.7–20.2)
FEV1 mean (SD) 75.3 (26.5) 75.6 (15.7) 0.9
FeNO median (first–third quartile) 17 (10.8–31.5) 16 (9.8–41) 0.9

Abbreviations: BMI, body mass index; C‐ACT, childhood asthma control test; FEV1, forced expiratory
volume in the first second; FeNo, fractional exhaled nitric oxide; ICS, inhaled corticosteroids;
LTRA, leukotriene receptor antagonist.
THAKUR ET AL. | 5

T A B L E 2 Comparison of primary and Parameter Vitamin D (n = 28) Placebo (n = 28) p Value

secondary outcomes at the end of the study
Primary outcome
C‐ACT score at 3 months
Median (first–third quartile) 25 (24–26) 25 (24–26) 0.7

Secondary outcome
Vitamin D post intervention
Mean (SD) 35.47 (10.0) 18.78 (6.6) <0.001
FEV1 mean (SD) 97.3 (14.4) 103.3(20.6) 0.2
FeNO
Median (first–third quartile) 16 (10–24.5) 10 (8.3–21.8) 0.2
No. of exacerbations
Median (first‐third quartile) 0 (0–0) 0 (0–0.3) 0.3
No. of patients with exacerbation, n (%) 4 (14.3) 7 (25) 0.3
Adverse outcomes, n (%) 0 0 NA
Emergency visits, n (%) 0 0 NA
Use of systematic steroids, n (%) 4 (14.3) 7 (25) 0.3

Abbreviations: C‐ACT, childhood asthma control test; FEV1, forced expiratory volume in the 1 s;
FeNo, fractional exhaled nitric oxide.

Only one participant in the intervention group had polyuria;
however, his vitamin D and calcium level were normal at that time,
and polyuria improved in 72 h. None of the participants experienced
hypercalcemia or vitamin D toxicity.
4 | D I S C U S SI O N
In this RCT, daily supplementation of 2000 IU of vitamin D in chil-
dren in addition to standard treatment of asthma did not show any
significant improvement in asthma control assessed by the C‐ACT
score after 12 weeks. Moreover, vitamin D supplementation had no
significant favorable effect on the secondary outcome, including
pulmonary function test, FeNO, number of asthma exacerbation,
emergency visit, and use of systemic steroids. However, vitamin D
levels significantly improved in the intervention group at 12 weeks.
Although observational studies showed a low level of vitamin D
level in children with asthma, however, experimental studies on vitamin
D supplementation in asthma in children showed conflicting evi-
dence.13–16 Therefore, the conventional concept of vitamin D therapy in
asthma may work by its immunogenic effect is still controversial.
A Cochrane review17 showed that vitamin D supplementation reduced
the risk of asthma exacerbations; however, there was no effect on ACT
score and FEV1. Like our study, the recently conducted vitamin‐D‐kids
asthma trial18 also did not find any significant impact of vitamin D
supplementation over severe asthma exacerbations. Moreover, the
studies on the role of antenatal supplementation of vitamin D did not
show any role in asthma in offspring by 6 years of age and complement
the findings of our study.19,20
In contrast to our findings, an RCT by Tachimoto et al.21; observed
significant improvement in asthma control in the vitamin D group. The
study had an unequal distribution of children in the groups, and both
controlled and uncontrolled asthma children were included. Furthermore,
Yadav et al.22 from India also observed that vitamin D significantly re-
duced asthma severity in children. However, the authors used a monthly
high dose of vitamin D, and both moderate and severe asthma patients
were included. Therefore, their findings cannot be directly compared with
this study.
The findings of our trial cannot be attributed to the fact that
vitamin D level did not significantly improve after vitamin D sup-
plementation. Since the mean vitamin D level in the intervention
group was above 20 ng/ml (sufficiency level). We used a daily dose

T A B L E 3 Comparison of clinical and biochemical parameters at baseline and end of the study period
Vitamin D Placebo

Parameter Baseline (n = 28) 3 Months (n = 28) p Value Baseline (n‐28) 3 Months (n = 28) p Value

Vitamin D3, mean (SD) 15.7 (8.5) 35.5 (10) <0.001 16.7 (10.2) 18.8 (6.7) 0.2

C‐ACT score, mean (SD) 18.0 (2.9) 24.5 (2.5) <0.001 15.6 (2.7) 24.5 (2.8) <0.001

FEV1, Mean (SD) 76.1 (26.8) 97.3 (14.4) <0.001 75.6 (16.1) 103.3 (20.6) <0.001

FeNO, Median (first−third quartile) 16.5 (10.3–29) 16 (10–24.5) 0.9 16 (10.3–43) 10 (8.3–21.8) 0.006

Abbreviations: C‐ACT, childhood asthma control test; FEV1, forced expiratory volume in the 1 s; FeNo, fractional exhaled nitric oxide.
6 |
of vitamin D 2000 IU per day below the recommended tolerable
upper limit,23 which had led to significant improvement in serum
vitamin D level in children of the intervention group. Children
tolerated this dose well since none of the children developed vi-
tamin D toxicity or hypercalcemia.
The strength of this RCT is that we used validate C‐ACT
score, the moderate daily dose of vitamin D and the follow‐up
system of this study was also robust to assess the compliance of
vitamin D since we asked parents to bring empty strips of con-
sumed tablets. However, there were several limitations to this
study. First, the duration of the study was short, so we could not
assess whether vitamin D supplementation leads to a reduction in
the dose of inhaled ICS. Second, the sample size of this study was
small and it was not powered for secondary outcomes. Third, we
used ICS and LABA in both intervention and control group which
appeared to be very effective in asthma control in both group as
median C‐ACT score was 25, therefore, it is unlikely that addition
of any intervention on the top of this will make any further im-
pact on primary outcome. Lastly, we enrolled six to eleven‐year
children with moderate persistent asthma, hence, the findings of
our study cannot be extrapolated to other age and asthma
severity.
In conclusion, medium‐dose, short‐term vitamin D supplementa-
tion, in addition to standard treatment, may not improve asthma
control in children. Further larger multi‐centric trials are required with
adequate power, long‐term follow‐up, and different doses of vitamin‐D
and asthma control medication to determine the role of vitamin‐D in
asthmatic children.
CO NFLICT OF I NTERE STS
The authors declare that there are no conflict of interests.
A UT HO R C ONT RI BU TIO NS
Chirag Thakur: data curation (lead); writing original draft (supporting).
Jogender Kumar: formal analysis (supporting); methodology (lead); writ-
ing review & editing (lead). Prawin Kumar: conceptualization (lead);
methodology (supporting); writing review & editing (supporting). Jagdish
Prasad Goyal: conceptualization (lead); methodology (supporting); writing
review & editing (lead). Kuldeep Singh: project administration (lead);
writing review & editing (supporting). Atul Gupta: validation (lead); writ-
ing review & editing (supporting).
D A T A A V A I L A B I LI TY S TA T E ME N T
The authors confirm that the data supporting the findings of this
study are available within the article.
OR CID
Jagdish Prasad Goyal https://orcid.org/0000-0002-7198-6909
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| 7
How to cite this article: Thakur C, Kumar J, Kumar P, Goyal JP,
Singh K, Gupta A. Vitamin‐D supplementation as an adjunct to
standard treatment of asthma in children: A randomized
controlled trial (ViDASTA Trial). Pediatric Pulmonology. 2021;1‐7.
https://doi.org/10.1002/ppul.25287