Vitamin D Needs of Early Adolescent Children
23. september 2015 opdateret af: Dr. Richard D. Lewis, University of Georgia
Supplemental Vitamin D and Functional Outcomes in Early Adolescence
While a large percentage of children have low blood vitamin D levels, the significance of these low levels and the impact on health is unclear.
The purpose of this project is to determine the effects of varying doses of vitamin D supplementation over 12 weeks on blood indicators of health in white and black children, aged 9 to 13 years, from both the northern and southern US.
Studieoversigt
Detaljeret beskrivelse
Vitamin D intakes in children do not meet current US Dietary Reference Intake recommendations and emerging evidence suggests that a significant number of children, particularly those with darker skin pigmentation, have inadequate levels of serum 25-hydroxyvitamin D [25(OH)D].
The optimum level of circulating 25(OH)D has not been clearly defined in children, nor is it known what functional outcome measures are ideal for defining this level, or if these requirements would differ by race.
Graded doses of vitamin D3 supplementation will be used in this dual-site, 12-week trial.
The investigators hypothesize that a dose-response relationship will be observed between vitamin D supplementation and intermediate endpoints of skeletal health, and that race will modify these responses.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
323
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Georgia
-
Athens, Georgia, Forenede Stater, 30602
- The University of Georgia Dept of Foods & Nutrition
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University School of Medicine
-
West Lafayette, Indiana, Forenede Stater, 47907
- Purdue University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
9 år til 13 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy
- Non-Hispanic
- Male, 10-13 years of age or female 9-11 years of age
- Within genitalia or breast stage 2/3
- Willing to provide blood/urine samples
- Free from taking vitamin, mineral or herbal supplements
- Able to swallow tablets
Exclusion Criteria:
- Menarche (females)
- Known bone diseases or disease known to influence bone metabolism (e.g. cerebral palsy, intestinal malabsorption, juvenile rheumatoid arthritis)
- Known growth disorder
- The use of medications that influence bone metabolism (e.g. corticosteroids, Attention Deficit Hyperactivity Disorder (ADHD) medications).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
placebotablet
|
vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks
|
|
Eksperimentel: 400 IU
Vitamin D3 tablet, 400 IU
|
vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks
|
|
Eksperimentel: 1,000 IU
Vitamin D3 tablet, 1,000 IU
|
vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks
|
|
Eksperimentel: 2,000 IU
Vitamin D3 tablet, 2,000 IU
|
vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks
|
|
Eksperimentel: 4,000 IU
Vitamin D3 tablet, 4,000 IU
|
vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
serum 25(OH)D
Tidsramme: 0 weeks
|
0 weeks
|
|
PTH
Tidsramme: 0 weeks
|
0 weeks
|
|
1,25(OH)2D
Tidsramme: 0 weeks
|
0 weeks
|
|
fractional calcium absorption
Tidsramme: 0 weeks
|
0 weeks
|
|
biochemical markers of bone turnover
Tidsramme: 0 weeks
|
0 weeks
|
|
serum 25(OH)D
Tidsramme: 3 weeks
|
3 weeks
|
|
serum 25(OH)D
Tidsramme: 6 weeks
|
6 weeks
|
|
serum 25(OH)D
Tidsramme: 9 weeks
|
9 weeks
|
|
serum 25(OH)D
Tidsramme: 12 weeks
|
12 weeks
|
|
PTH
Tidsramme: 3 weeks
|
3 weeks
|
|
PTH
Tidsramme: 6 weeks
|
6 weeks
|
|
PTH
Tidsramme: 9 weeks
|
9 weeks
|
|
PTH
Tidsramme: 12 weeks
|
12 weeks
|
|
1,25(OH)2D
Tidsramme: 3 weeks
|
3 weeks
|
|
1,25(OH)2D
Tidsramme: 6 weeks
|
6 weeks
|
|
1,25(OH)2D
Tidsramme: 9 weeks
|
9 weeks
|
|
1,25(OH)2D
Tidsramme: 12 weeks
|
12 weeks
|
|
fractional calcium absorption
Tidsramme: 12 weeks
|
12 weeks
|
|
biochemical markers of bone turnover
Tidsramme: 3 weeks
|
3 weeks
|
|
biochemical markers of bone turnover
Tidsramme: 6 weeks
|
6 weeks
|
|
biochemical markers of bone turnover
Tidsramme: 9 weeks
|
9 weeks
|
|
biochemical markers of bone turnover
Tidsramme: 12 weeks
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
kropssammensætning
Tidsramme: 12 uger
|
12 uger
|
|
sunlight exposure
Tidsramme: 0 weeks
|
0 weeks
|
|
dietary data
Tidsramme: 0 weeks
|
0 weeks
|
|
physical activity data
Tidsramme: 0 weeks
|
0 weeks
|
|
serum and urinary calcium
Tidsramme: 0 weeks
|
0 weeks
|
|
body composition
Tidsramme: 0 weeks
|
0 weeks
|
|
sunlight exposure
Tidsramme: 3 weeks
|
3 weeks
|
|
sunlight exposure
Tidsramme: 6 weeks
|
6 weeks
|
|
sunlight exposure
Tidsramme: 9 weeks
|
9 weeks
|
|
sunlight exposure
Tidsramme: 12 weeks
|
12 weeks
|
|
dietary data
Tidsramme: 3 weeks
|
3 weeks
|
|
dietary data
Tidsramme: 6 weeks
|
6 weeks
|
|
dietary data
Tidsramme: 9 weeks
|
9 weeks
|
|
dietary data
Tidsramme: 12 weeks
|
12 weeks
|
|
physical activity data
Tidsramme: 3 weeks
|
3 weeks
|
|
physical activity data
Tidsramme: 6 weeks
|
6 weeks
|
|
physical activity data
Tidsramme: 9 weeks
|
9 weeks
|
|
physical activity data
Tidsramme: 12 weeks
|
12 weeks
|
|
serum and urinary calcium
Tidsramme: 3 weeks
|
3 weeks
|
|
serum and urinary calcium
Tidsramme: 6 weeks
|
6 weeks
|
|
serum and urinary calcium
Tidsramme: 9 weeks
|
9 weeks
|
|
serum and urinary calcium
Tidsramme: 12 weeks
|
12 weeks
|
|
body composition
Tidsramme: 3 weeks
|
3 weeks
|
|
body composition
Tidsramme: 6 weeks
|
6 weeks
|
|
body composition
Tidsramme: 9 weeks
|
9 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Richard D Lewis, PhD, The University of Georgia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Lewis RD, Laing EM, Hill Gallant KM, Hall DB, McCabe GP, Hausman DB, Martin BR, Warden SJ, Peacock M, Weaver CM. A randomized trial of vitamin D(3) supplementation in children: dose-response effects on vitamin D metabolites and calcium absorption. J Clin Endocrinol Metab. 2013 Dec;98(12):4816-25. doi: 10.1210/jc.2013-2728. Epub 2013 Oct 3.
- Wright CS, Laing EM, Pollock NK, Hausman DB, Weaver CM, Martin BR, McCabe GP, Peacock M, Warden SJ, Hill Gallant KM, Lewis RD. Serum 25-Hydroxyvitamin D and Intact Parathyroid Hormone Influence Muscle Outcomes in Children and Adolescents. J Bone Miner Res. 2018 Nov;33(11):1940-1947. doi: 10.1002/jbmr.3550. Epub 2018 Aug 27.
- Giudici KV, Kindler JM, Martin BR, Laing EM, McCabe GP, McCabe LD, Hausman DB, Martini LA, Lewis RD, Weaver CM, Peacock M, Hill Gallant KM. Associations among osteocalcin, leptin and metabolic health in children ages 9-13 years in the United States. Nutr Metab (Lond). 2017 Mar 7;14:25. doi: 10.1186/s12986-017-0171-9. eCollection 2017.
- Ferira AJ, Laing EM, Hausman DB, Hall DB, McCabe GP, Martin BR, Hill Gallant KM, Warden SJ, Weaver CM, Peacock M, Lewis RD. Vitamin D Supplementation Does Not Impact Insulin Resistance in Black and White Children. J Clin Endocrinol Metab. 2016 Apr;101(4):1710-8. doi: 10.1210/jc.2015-3687. Epub 2016 Feb 17.
- Hill KM, Laing EM, Hausman DB, Acton A, Martin BR, McCabe GP, Weaver CM, Lewis RD, Peacock M. Bone turnover is not influenced by serum 25-hydroxyvitamin D in pubertal healthy black and white children. Bone. 2012 Oct;51(4):795-9. doi: 10.1016/j.bone.2012.06.014. Epub 2012 Jun 28.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2009
Primær færdiggørelse (Faktiske)
1. april 2011
Studieafslutning (Faktiske)
1. april 2011
Datoer for studieregistrering
Først indsendt
1. juli 2009
Først indsendt, der opfyldte QC-kriterier
1. juli 2009
Først opslået (Skøn)
2. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. september 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. september 2015
Sidst verificeret
1. september 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R01HD57126-01A2 UGA
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .