Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
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50 nmol/L (Öhlund I, unpublished data).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.


Options:
A: Arm Label: xylitol wipe; Type: EXPERIMENTAL; Interventions: Dietary Supplement: xylitol wipe | Arm Label: placebo wipe; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: placebo wipe | Intervention Type: DIETARY_SUPPLEMENT; Name: xylitol wipe; Assigned to Arm(s): xylitol wipe | Intervention Type: DIETARY_SUPPLEMENT; Name: placebo wipe; Assigned to Arm(s): placebo wipe
B: Arm Label: Prenatal MI - Postpartum MI; Type: EXPERIMENTAL; Interventions: Behavioral: motivational interviewing counseling | Arm Label: Prenatal MI - Postpartum Health Ed; Type: EXPERIMENTAL; Interventions: Behavioral: motivational interviewing counseling | Arm Label: Prenatal Health Ed - Postpartum MI; Type: EXPERIMENTAL; Interventions: Behavioral: motivational interviewing counseling | Arm Label: Prenatal Health Ed/Postpartum Health Ed; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: health education | Intervention Type: BEHAVIORAL; Name: motivational interviewing counseling; Assigned to Arm(s): Prenatal MI - Postpartum MI | Intervention Type: BEHAVIORAL; Name: motivational interviewing counseling; Assigned to Arm(s): Prenatal MI - Postpartum Health Ed | Intervention Type: BEHAVIORAL; Name: motivational interviewing counseling; Assigned to Arm(s): Prenatal Health Ed - Postpartum MI | Intervention Type: BEHAVIORAL; Name: health education; Assigned to Arm(s): Prenatal Health Ed/Postpartum Health Ed
C: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Peer-support for exclusive breastfeeding | Arm Label: No intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Peer-support for exclusive breastfeeding; Assigned to Arm(s): Intervention
D: Arm Label: Umeå, vitamin D 25 microg/d, light skin; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D 25 microg/d | Arm Label: Umeå, vitamin D 10 microg/d, dark skin; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D 10 microg/d | Arm Label: Umeå, vitamin D 10 microg/d, light skin; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D 10 microg/d | Arm Label: Malmö, vitamin D 25 microg/d, dark skin; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D 25 microg/d | Arm Label: Malmö, vitamin D 25 microg/d, light skin; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D 25 microg/d | Arm Label: Malmö, vitamin D 10 microg/d, dark skin; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D 10 microg/d | Arm Label: Malmö, vitamin D 10 microg/d, light skin; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D 10 microg/d | Arm Label: Malmö, placebo, dark skin,; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: No extra vitamin D | Arm Label: Malmö, placebo, light skin; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: No extra vitamin D | Arm Label: Umeå, vitamin D 25 microg/d, dark skin; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D 25 microg/d | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D 25 microg/d; Assigned to Arm(s): Malmö, vitamin D 25 microg/d, dark skin, Malmö, vitamin D 25 microg/d, light skin, Umeå, vitamin D 25 microg/d, dark skin, Umeå, vitamin D 25 microg/d, light skin | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D 10 microg/d; Assigned to Arm(s): Malmö, vitamin D 10 microg/d, dark skin, Malmö, vitamin D 10 microg/d, light skin, Umeå, vitamin D 10 microg/d, dark skin, Umeå, vitamin D 10 microg/d, light skin | Intervention Type: DIETARY_SUPPLEMENT; Name: No extra vitamin D; Assigned to Arm(s): Malmö, placebo, dark skin,, Malmö, placebo, light skin

Answer: D