NCT01741324

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50 nmol/L (Öhlund I, unpublished data).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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

November 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

November 26, 2012

Last Update Submit

October 31, 2016

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Serum 25OH-vitamin D levels

    90 days after start of treatment

Secondary Outcomes (1)

  • Bone mineralisation

    120 days after start of treatment

Other Outcomes (2)

  • Inflammatory and immunological markers

    90 days after start of treatment

  • Behavioral and emotional well-being

    90 days after start of treatment

Study Arms (10)

Umeå, vitamin D 25 microg/d, light skin

EXPERIMENTAL

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

Umeå, vitamin D 10 microg/d, dark skin

ACTIVE COMPARATOR

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

Umeå, vitamin D 10 microg/d, light skin

ACTIVE COMPARATOR

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

Malmö, vitamin D 25 microg/d, dark skin

EXPERIMENTAL

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

Malmö, vitamin D 25 microg/d, light skin

EXPERIMENTAL

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

Malmö, vitamin D 10 microg/d, dark skin

ACTIVE COMPARATOR

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

Malmö, vitamin D 10 microg/d, light skin

ACTIVE COMPARATOR

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

Malmö, placebo, dark skin,

PLACEBO COMPARATOR

Participants with dark skin will be randomized to a milk drink without added vitamin D (placebo).

Dietary Supplement: No extra vitamin D

Malmö, placebo, light skin

PLACEBO COMPARATOR

Participants with light skin will be randomized to a milk drink without added vitamin D (placebo).

Dietary Supplement: No extra vitamin D

Umeå, vitamin D 25 microg/d, dark skin

EXPERIMENTAL

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

Interventions

Vitamin D 25 microg/dDIETARY_SUPPLEMENT

The vitamin D supplement will be provided as a milk drink taken daily.

Malmö, vitamin D 25 microg/d, dark skinMalmö, vitamin D 25 microg/d, light skinUmeå, vitamin D 25 microg/d, dark skinUmeå, vitamin D 25 microg/d, light skin
Vitamin D 10 microg/dDIETARY_SUPPLEMENT

The vitamin D supplement will be provided as a milk drink taken daily.

Malmö, vitamin D 10 microg/d, dark skinMalmö, vitamin D 10 microg/d, light skinUmeå, vitamin D 10 microg/d, dark skinUmeå, vitamin D 10 microg/d, light skin
No extra vitamin DDIETARY_SUPPLEMENT

Milk drink with no extra vitamin D (placebo)

Also known as: Placebo
Malmö, placebo, dark skin,Malmö, placebo, light skin

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • Healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Pediatrics, University hospital Malmö

Malmo, Skåne County, 20502, Sweden

Location

Pediatrics, Department of Clinical Sciences, Umeå University

Umeå, Västerbotten County, 90187, Sweden

Location

Related Publications (19)

  • Prentice A, Goldberg GR, Schoenmakers I. Vitamin D across the lifecycle: physiology and biomarkers. Am J Clin Nutr. 2008 Aug;88(2):500S-506S. doi: 10.1093/ajcn/88.2.500S.

    PMID: 18689390BACKGROUND

  • Holick MF. The vitamin D deficiency pandemic and consequences for nonskeletal health: mechanisms of action. Mol Aspects Med. 2008 Dec;29(6):361-8. doi: 10.1016/j.mam.2008.08.008. Epub 2008 Sep 2.

    PMID: 18801384BACKGROUND

  • Dawson-Hughes B, Heaney RP, Holick MF, Lips P, Meunier PJ, Vieth R. Estimates of optimal vitamin D status. Osteoporos Int. 2005 Jul;16(7):713-6. doi: 10.1007/s00198-005-1867-7. Epub 2005 Mar 18.

    PMID: 15776217BACKGROUND

  • Huh SY, Gordon CM. Vitamin D deficiency in children and adolescents: epidemiology, impact and treatment. Rev Endocr Metab Disord. 2008 Jun;9(2):161-70. doi: 10.1007/s11154-007-9072-y. Epub 2008 Jan 4.

    PMID: 18175220BACKGROUND

  • Yetley EA. Assessing the vitamin D status of the US population. Am J Clin Nutr. 2008 Aug;88(2):558S-564S. doi: 10.1093/ajcn/88.2.558S.

    PMID: 18689402BACKGROUND

  • Greer FR. Defining vitamin D deficiency in children: beyond 25-OH vitamin D serum concentrations. Pediatrics. 2009 Nov;124(5):1471-3. doi: 10.1542/peds.2009-2307. Epub 2009 Oct 26. No abstract available.

    PMID: 19858159BACKGROUND

  • Cashman KD, FitzGerald AP, Viljakainen HT, Jakobsen J, Michaelsen KF, Lamberg-Allardt C, Molgaard C. Estimation of the dietary requirement for vitamin D in healthy adolescent white girls. Am J Clin Nutr. 2011 Mar;93(3):549-55. doi: 10.3945/ajcn.110.006577. Epub 2011 Jan 26.

    PMID: 21270380BACKGROUND

  • Brustad M, Edvardsen K, Wilsgaard T, Engelsen O, Aksnes L, Lund E. Seasonality of UV-radiation and vitamin D status at 69 degrees north. Photochem Photobiol Sci. 2007 Aug;6(8):903-8. doi: 10.1039/b702947k. Epub 2007 Jun 27.

    PMID: 17668121BACKGROUND

  • Edvardsen K, Brustad M, Engelsen O, Aksnes L. The solar UV radiation level needed for cutaneous production of vitamin D3 in the face. A study conducted among subjects living at a high latitude (68 degrees N). Photochem Photobiol Sci. 2007 Jan;6(1):57-62. doi: 10.1039/b613263d. Epub 2006 Nov 10.

    PMID: 17200737BACKGROUND

  • Holick MF. The vitamin D epidemic and its health consequences. J Nutr. 2005 Nov;135(11):2739S-48S. doi: 10.1093/jn/135.11.2739S.

    PMID: 16251641BACKGROUND

  • Stechschulte SA, Kirsner RS, Federman DG. Sunscreens for non-dermatologists: what you should know when counseling patients. Postgrad Med. 2011 Jul;123(4):160-7. doi: 10.3810/pgm.2011.07.2315.

    PMID: 21681000BACKGROUND

  • Prentice A. Vitamin D deficiency: a global perspective. Nutr Rev. 2008 Oct;66(10 Suppl 2):S153-64. doi: 10.1111/j.1753-4887.2008.00100.x.

    PMID: 18844843BACKGROUND

  • Garemo M, Lenner RA, Strandvik B. Swedish pre-school children eat too much junk food and sucrose. Acta Paediatr. 2007 Feb;96(2):266-72. doi: 10.1111/j.1651-2227.2007.00093.x.

    PMID: 17429918BACKGROUND

  • 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.

    BACKGROUND

  • Ohlund K, Olsson C, Hernell O, Ohlund I. Dietary shortcomings in children on a gluten-free diet. J Hum Nutr Diet. 2010 Jun;23(3):294-300. doi: 10.1111/j.1365-277X.2010.01060.x. Epub 2010 Mar 23.

    PMID: 20337845BACKGROUND

  • Ohlund I, Lind T, Hernell O, Silfverdal SA, Liv P, Karlsland Akeson P. Vitamin D status and cardiometabolic risk markers in young Swedish children: a double-blind randomized clinical trial comparing different doses of vitamin D supplements. Am J Clin Nutr. 2020 Apr 1;111(4):779-786. doi: 10.1093/ajcn/nqaa031.

    PMID: 32140704DERIVED

  • Karlsland Akeson P, Akesson KE, Lind T, Hernell O, Silfverdal SA, Ohlund I. Vitamin D Intervention and Bone: A Randomized Clinical Trial in Fair- and Dark-skinned Children at Northern Latitudes. J Pediatr Gastroenterol Nutr. 2018 Sep;67(3):388-394. doi: 10.1097/MPG.0000000000002031.

    PMID: 29851760DERIVED

  • Gyll J, Ridell K, Ohlund I, Karlsland Akeson P, Johansson I, Lif Holgerson P. Vitamin D status and dental caries in healthy Swedish children. Nutr J. 2018 Jan 16;17(1):11. doi: 10.1186/s12937-018-0318-1.

    PMID: 29338758DERIVED

  • Ohlund I, Lind T, Hernell O, Silfverdal SA, Karlsland Akeson P. Increased vitamin D intake differentiated according to skin color is needed to meet requirements in young Swedish children during winter: a double-blind randomized clinical trial. Am J Clin Nutr. 2017 Jul;106(1):105-112. doi: 10.3945/ajcn.116.147108. Epub 2017 Jun 14.

    PMID: 28615261DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Inger Öhlund, Ph.D.

    Umeå University

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 26, 2012

First Posted

December 4, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2013

Study Completion

July 1, 2013

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

SE(2)