Ultivit™ Kids - Clinical Trials
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||I Clinical Trials
||I Research Brief
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Indication: prevention of hypovitaminosis, hyperexcitability and undue fatiguability in children; intense mental and physical activity.
Actions: provides vitally essential combination of vitamins and minerals, prevents hypovitaminosis in children, promotes overall health, strengthens musculoskeletal system, contains antioxidants, prevents damage caused by free radicals, normalizes metabolism, enhances the immune system, contains iron to prevent iron deficiency anemia.
Ingredients (per 1 tablet): Vitamin A (as beta-carotene) - 2400 IU, Vitamin B1 (as thiamin HCL) – 1.4 mg, Vitamin B2 (as riboflavin) – 1.6 mg, Niacin (as niacinamide) - 10 mg, Pantothenic Acid (as D-calcium pantothenate) – 3.3 mg, Vitamin B6 (as pyridoxine HCL) - 2.0 mg, Folic Acid - 200 mcg, Vitamin B12 (as cyanocobalamin) – 3.0 mcg, Vitamin C (as ascorbic acid and sodium ascorbate) - 50 mg, Vitamin D (as cholecalciferol) - 100 IU, Vitamin E (as d-alpha-tocopheryl succinate) - 10 IU, Iron (as carbonyl iron) - 9 mg, Magnesium (as magnesium citrate) - 5 mg, Manganese (as manganese gluconate) - 1 mg, Zinc (as zinc citrate) - 1 mg, Iodine (as potassium iodide) - 50 mcg, Potassium (as potassium citrate) - 1.5 mg.
Ultivit™ Kids - Clinical Trials:
OBJECTIVE: To compare the food consumption and nutrient intakes of German children and adolescents in the 1980s with present dietary habits.
DESIGN: Two cross-sectional representative surveys, the German National Food Consumption Study (Nationale Verzehrsstudie, NVS) from 1985-8 and the nutrition module 'EsKiMo' of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) from 2006, were analyzed for differences in food and nutrient intakes stratified by age and sex groups. SETTING: Secondary analyses of data from representative observational studies.
SUBJECTS: Children and adolescents aged 6-17 years living in Germany in the 1980s (n 2265) and in 2006 (n 2506).
RESULTS: Food consumption was characterized by higher amounts of vegetables/pulses, fruits/nuts and beverages and less meat products/sausages, butter, fats/oils, potatoes/potato products and bread/pastries in 2006 than in 1985-8. The overall changes in food intake were reflected in improvements of macronutrient composition, increased water intake and lower energy density of the diet.
Intake of most vitamins and minerals increased in relation to energy intake, but the nutrient density of the diet for vitamins B12 and D decreased.
The most critical nutrients observed in NVS and EsKiMo were folate, vitamin D, vitamin A, vitamin E, Ca and Fe. In addition, dietary fiber intake was relatively low and fatty acid and carbohydrate compositions were not favorable.
CONCLUSIONS: Further efforts will be necessary to improve dietary habits among children and adolescents. (6)
A recent UK-based study investigated whether daily supplementation with vitamins/minerals could modulate cognitive performance and mood in healthy children. In this investigation, eighty-one healthy children aged from 8 to 14 years underwent laboratory assessments of their cognitive performance and mood on the first and last days of 12 weeks' supplementation with a commercially available vitamins/mineral product.
The assessment was done at pre-dose, 1h and 3h post-dose. Interim assessments were also completed at home after 4 and 8 weeks at 3 h post-dose. Each assessment comprised completion of a cognitive battery, which included tasks assessing mood and the speed and accuracy of attention and aspects of memory (secondary, semantic and spatial working memory).
The vitamin/mineral group performed more accurately on two attention tasks: 'Arrows' choice reaction time task at 4 and 8 weeks; and 'Arrow Flankers' choice reaction time task at 4, 8 and 12 weeks. Picture Recognition errors showed significant decrement at 12 weeks.
While mood was not modulated in any interpretable manner, the author believes that these results suggest that vitamin/mineral supplementation has the potential to improve brain function in healthy children, and warrant further investigation. (7)
716 girls who enrolled at four Baltimore high schools were screened for non-anaemic iron deficiency (serum ferritin < or = 12 micrograms/L with normal haemoglobin). 98 (13.7%) girls had non-anaemic iron deficiency of whom 81 were enrolled in the trial.
Participants were randomly assigned oral ferrous sulphate (650 mg twice daily) or placebo for 8 weeks. The effect of iron treatment was assessed by questionnaires and haematological and cognitive tests, which were done before treatment started and repeated after the intervention. We used four tests of attention and memory to measure cognitive functioning. Intention-to-treat and per-protocol analyses were done.
Of the 81 enrolled girls with non-anaemic iron deficiency, 78 (96%) completed the study (39 in each group). Five girls (three control, two treatment) developed anaemia during the intervention and were excluded from the analyses. Thus, 73 girls were included in the per-protocol analysis. Ethnic distribution, mean age, serum ferritin concentrations, haemoglobin concentrations, and cognitive test scores of the groups did not differ significantly at baseline. Postintervention haematological measures of iron status were significantly improved in the treatment group (serum ferritin 27.3 vs 12.1 micrograms/L, p < 0.001).
Regression analysis showed that girls who received iron performed better on a test of verbal learning and memory than girls in the control group (p < 0.02). (8)
Low levels of vitamin D were associated with an increased risk of high blood pressure, high blood sugar and metabolic syndrome in teenagers, researchers reported at the American Heart Association’s 49th Annual Conference on Cardiovascular Disease Epidemiology and Prevention.
In the study, researchers analyzed 3,577 adolescents, 12 to 19 years old (51 percent boys), who participated in the nationally representative National Health and Nutrition Examination Survey (NHANES) conducted in 2001–2004.
After adjusting for age, sex, race/ethnicity, body mass index, socioeconomic status and physical activity, researchers found the adolescents with the lowest levels of vitamin D were:
• 2.36 times more likely to have high blood pressure;
• 2.54 times more likely to have high blood sugar; and
• 3.99 times more likely to have metabolic syndrome.
Metabolic syndrome is a cluster of cardiovascular disease and diabetes risk factors including elevated waist circumference, high blood pressure, elevated triglycerides, low levels of high-density lipoprotein (HDL or “good”) cholesterol and high fasting glucose levels. The presence of three or more of the factors increases a person’s risk of developing diabetes and cardiovascular disease.
Low levels of vitamin D are strongly associated with overweight and abdominal obesity. (9)
Catherine M. Gordon, M.D., M.Sc., and colleagues at Children's Hospital Boston, studied 380 healthy children ages 8 months to 24 months who visited a primary care center for a physical examination between 2005 and 2007. Parents filled out a questionnaire regarding their nutritional intake and that of their children, and also reported on the use of vitamin D and other supplements, time spent outdoors, socioeconomic status and education level.
Among the 365 children for whom blood samples were available, 12.1 percent (44) had vitamin D deficiency, defined as 20 nanograms per milliliter of blood or less, and 40 percent (146) had levels below the accepted optimal level of 30 nanograms per milliliter. Breastfed infants who did not receive vitamin D and toddlers who drank less milk were at higher risk of deficiency (for each cup of milk toddlers drank per day, blood vitamin D level increased by 2.9 nanograms per milliliter).
Forty children of the 44 with vitamin D deficiency underwent X-rays of the wrist and knee. Thirteen (32.5 percent) had evidence of bone mineral loss, and three (7.5 percent) exhibited changes to their bones suggestive of rickets.
The data suggest that infants should receive vitamin D supplements while breastfeeding and raise the question of whether some children, including those with established risk factors for vitamin D deficiency, should receive regular measurements of blood vitamin D levels. (10)
Pneumonia is a leading cause of morbidity and mortality in young children.
In a double-blind placebo-controlled clinical trial in Matlab Hospital, Bangladesh, 270 children aged 2-23 months were randomized to receive elemental zinc (20 mg per day) or placebo, plus the hospital's standard antimicrobial management, until discharge.
The outcomes were time to cessation of severe pneumonia (no chest indrawing, respiratory rate 50 per min or less, oxygen saturation at least 95% on room air) and discharge from hospital. Discharge was allowed when respiratory rate was 40 per minute or less for 24 consecutive hours while patients were maintained only on oral antibiotics.
The group receiving zinc had reduced duration of severe pneumonia (relative hazard [RH]=0.70, 95% CI 0.51-0.98), including duration of chest indrawing (0.80, 0.61-1.05), respiratory rate more than 50 per min (0.74, 0.57-0.98), and hypoxia (0.79, 0.61-1.04), and overall hospital duration (0.75, 0.57-0.99). The mean reduction is equivalent to 1 hospital day for both severe pneumonia and time in hospital. All effects were greater when children with wheezing were omitted from the analysis.
Adjuvant treatment with 20 mg zinc per day accelerates recovery from severe pneumonia in children. (11)
OBJECTIVES: Folate and the metabolically related B vitamins are an important priority throughout life, but few studies have examined their status through childhood and adolescence.
The aims of the current study were to investigate age, gender, and lifestyle factors as determinants of folate, related B-vitamin status, and homocysteine concentrations among British children and adolescents and to propose age-specific reference ranges for these biomarkers, which, at present, are unavailable.
PARTICIPANTS AND METHODS: Data from the National Dietary and Nutritional Survey of 2127 young people aged 4 to 18 years were accessed to provide a representative sample of British children.
All of the subjects who provided a blood sample for homocysteine concentrations were included in the current study (n = 840). Of these, laboratory biomarkers of folate (serum and red cell folate: n = 832 and 774, respectively), vitamin B(12) (n = 828), vitamin B(6) (n = 770), and riboflavin (n = 839) were also examined.
RESULTS: The biomarker status of all 4 of the relevant B vitamins decreased significantly with age. Correspondingly, homocysteine concentrations progressively increased, with median values of 5.6, 6.3, and 7.9 mumol/L for children aged 4 to 10 years, 11 to 14 years, and 15 to 18 years, respectively, and were higher in boys compared with girls (15-18 years only). Independent of age and gender, fortified breakfast cereal intake (consumed by 89% of the sample) was associated with significantly higher B-vitamin status and lower homocysteine concentrations. (12)