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Comparing Different Amounts of Vitamin D Supplementation to Preschool Children Living in Northern and Southern Sweden (Dvisum)

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ClinicalTrials.gov Identifier: NCT01741324
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : November 1, 2016
Sponsor:
Collaborator:
Region Skane
Information provided by (Responsible Party):
Torbjörn Lind, Umeå University

Brief Summary:

Vitamin D has a range of biological effects of public health relevance. Vitamin D status is assessed on levels of its metabolite 25-hydroxyvitamin D [25(OH)D], where levels < 50 nmol/L indicate insufficiency. Despite studies indicating that the vitamin D intake among Swedish children are significantly below recommendations, little is known of their vitamin D status. The investigators have recently found inadequate vitamin D status in pre-school children living in northern Sweden, especially in dark-skinned children and during the winter months despite vitamin D intakes meeting the recommendations. Overall, 25% of the light skinned and 40% of the dark skinned children had S-25(OH) D <50 nmol/L (Öhlund I, unpublished data). The aim is to examine which amount of vitamin D is needed to maintain or increase S-25(OH)D to ≥50 nmol/L among 97.5% of the participants regardless of skin color or geographic location (northern or southern Sweden). Furthermore the investigators will examine if vitamin D status affects on health markers as bone density, blood pressure, serum lipids, fatty acids, inflammatory and immunological markers and mental wellbeing.

Children aged 5-8 years living either northern (Umeå) or southern Sweden (Malmö) will be recruited to this trial during November-December 2012. They will be randomized to a vitamin D supplement of either 10 or 25 g per day, or in Malmö also placebo to be used for three months. The randomization will be stratified according to skin color (light or dark) according to a method using visual inspection and interviews of parents/guardians. The investigators will use a 2×2×2 factorial design to investigate the effects of two different doses of vitamin D (10 µg and 25 µg) in children with dark and light skin color, living in northern (Umeå) and southern (Malmö), Sweden. In order to achieve a moderate difference between groups (effect size 0.25) 20 children per group are required (power> 87%, alpha = 0.05). With an estimated dropout of 10%, a total of 220 children will be included.

At baseline, the participants will undergo blood sampling for S-25(OH)D and other biomarkers, blood pressure and anthropometrical measurements, including bone densitometry and body composition using air displacement pletysmography, and the parents will answer a questionnaire on behavioral and emotional problems in the participating child using the Child Behavior Checklist. These measurements will be repeated at follow-up in February-March 2013.


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Vitamin D 25 microg/d Dietary Supplement: Vitamin D 10 microg/d Dietary Supplement: No extra vitamin D Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : November 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Umeå, vitamin D 25 microg/d, light skin
Participants with light skin will be randomized to a milk drink providing 25 microg vitamin D3 per day.
Dietary Supplement: Vitamin D 25 microg/d
The vitamin D supplement will be provided as a milk drink taken daily.

Active Comparator: Umeå, vitamin D 10 microg/d, dark skin
Participants with dark skin will be randomized to a milk drink providing 10 microg vitamin D3 per dag.
Dietary Supplement: Vitamin D 10 microg/d
The vitamin D supplement will be provided as a milk drink taken daily.

Active Comparator: Umeå, vitamin D 10 microg/d, light skin
Participants with light skin will be randomized to a milk drink providing 10 microg vitamin D3 per dag.
Dietary Supplement: Vitamin D 10 microg/d
The vitamin D supplement will be provided as a milk drink taken daily.

Experimental: Malmö, vitamin D 25 microg/d, dark skin
Participants with dark skin will be randomized to a milk drink providing 25 microg vitamin D3 per day.
Dietary Supplement: Vitamin D 25 microg/d
The vitamin D supplement will be provided as a milk drink taken daily.

Experimental: Malmö, vitamin D 25 microg/d, light skin
Participants with light skin will be randomized to a milk drink providing 10 microg vitamin D3 per day.
Dietary Supplement: Vitamin D 25 microg/d
The vitamin D supplement will be provided as a milk drink taken daily.

Active Comparator: Malmö, vitamin D 10 microg/d, dark skin
Participants with dark skin will be randomized to a milk drink providing 10 microg vitamin D3 per day.
Dietary Supplement: Vitamin D 10 microg/d
The vitamin D supplement will be provided as a milk drink taken daily.

Active Comparator: Malmö, vitamin D 10 microg/d, light skin
Participants with light skin will be randomized to a milk drink providing 10 microg vitamin D3 per day.
Dietary Supplement: Vitamin D 10 microg/d
The vitamin D supplement will be provided as a milk drink taken daily.

Placebo Comparator: Malmö, placebo, dark skin,
Participants with dark skin will be randomized to a milk drink without added vitamin D (placebo).
Dietary Supplement: No extra vitamin D
Milk drink with no extra vitamin D (placebo)
Other Name: Placebo

Placebo Comparator: Malmö, placebo, light skin
Participants with light skin will be randomized to a milk drink without added vitamin D (placebo).
Dietary Supplement: No extra vitamin D
Milk drink with no extra vitamin D (placebo)
Other Name: Placebo

Experimental: Umeå, vitamin D 25 microg/d, dark skin
Participants with dark skin will be randomized to a milk drink providing 25 microg vitamin D3 per day.
Dietary Supplement: Vitamin D 25 microg/d
The vitamin D supplement will be provided as a milk drink taken daily.




Primary Outcome Measures :
  1. Serum 25OH-vitamin D levels [ Time Frame: 90 days after start of treatment ]

Secondary Outcome Measures :
  1. Bone mineralisation [ Time Frame: 120 days after start of treatment ]
    Bone mineralisation will be measured with DXA-scan, serum PTH and serum osteocalcin


Other Outcome Measures:
  1. Inflammatory and immunological markers [ Time Frame: 90 days after start of treatment ]
    CRP, interleukin (IL) -1 and 2, IL-4, IL-6, I-10, Il-17, CD40 ligand, TNF-alfa, IFNγ, fibrinogen and antisecretory factor

  2. Behavioral and emotional well-being [ Time Frame: 90 days after start of treatment ]
    Parental assessment using Child Behavioral Checklist



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 5-7 years of age
  • Healthy

Exclusion Criteria:

  • Chronic illness, including coeliac disease or other chronic gastrointestinal disorders
  • Drugs that can affect bone health or vitamin D uptake
  • Cow's milk allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741324


Locations
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Sweden
Department of Pediatrics, University hospital Malmö
Malmö, Skåne, Sweden, 20502
Pediatrics, Department of Clinical Sciences, Umeå University
Umeå, Västerbotten, Sweden, 90187
Sponsors and Collaborators
Umeå University
Region Skane
Investigators
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Principal Investigator: Inger Öhlund, Ph.D. Umeå University
Study Chair: Torbjörn Lind, M.D., Ph.D. Umeå University
Study Chair: Pia Karlsland-Åkesson, M.D., Ph.D. University hospital, Malmö/Lund
Study Chair: Sven-Arne Silfverdal, M.D., Ph.D. Umeå University
Study Chair: Olle Hernell, M.D., Ph.D. Umeå University
Publications:
Enghardt B, Pearson M, Becker W. Dietary habits and nutrient intake in Swedish children 4 years old and school children in grade 2 and 5 (Riksmaten - barn 2003). Uppsala: National Food Administration (Livsmedelsverket), Uppsala, Sweden; 2006.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Torbjörn Lind, Associate professor, Umeå University
ClinicalTrials.gov Identifier: NCT01741324    
Other Study ID Numbers: Dvisum
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents