Evaluation of Calcium, Vitamin D, Magnesium, and Zinc Absorption in Children - Full Text View

Purpose

The goal of our research is to provide data to enhance the development of nutritional guidelines, especially as related to mineral nutrition, in children. Using human experimentation, we are studying methods of delivering the key minerals of calcium, zinc and iron in the diet so as to optimize health outcomes. We will conduct a controlled trial of vitamin D supplementation to assess the effects of vitamin D status on calcium absorption in small children. We will evaluate the effects of differing intakes of zinc on zinc and copper absorption. These studies will utilize stable isotope techniques so as to provide accurate, practically applicable information which may be obtained from the study populations in a safe manner. These data will have global application and provide a strong basis for evidence-based nutritional recommendations to be developed.

Objective #1: To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age.

Objective #2: Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of age.

Condition	Intervention
Mineral Absorption	Dietary Supplement: Vitamin D

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	Evaluation of Calcium, Vitamin D, Magnesium, and Zinc Absorption in Healthy Children 4 to 8 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dietary Supplements Minerals Vitamin D

Drug Information available for: Calcium Gluconate Vitamin D Magnesium

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age. [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of age. [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	March 2009
Study Completion Date:	October 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Vitamin D Subjects will be provided supplemental vitamin D3 (1000 IU), given once daily as a softgel or liquid. Subjects will be instructed to take the supplement daily for 8 weeks.	Dietary Supplement: Vitamin D Subjects will be provided supplemental vitamin D3 (1000 IU) or placebo, given once daily (based on the stratification noted above). Vitamin D/placebo will be provided using a softgel or liquid. Subjects will be instructed to take the supplement daily for 8 weeks.
Placebo Comparator: Placebo Subjects will be provided a placebo, given once daily as a softgel or liquid. Subjects will be instructed to take the supplement daily for 8 weeks.	Dietary Supplement: Vitamin D Subjects will be provided supplemental vitamin D3 (1000 IU) or placebo, given once daily (based on the stratification noted above). Vitamin D/placebo will be provided using a softgel or liquid. Subjects will be instructed to take the supplement daily for 8 weeks.

Show Detailed Description

Eligibility

Ages Eligible for Study:	4 Years to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Delivery at > or = 35.0 weeks gestation with birth weight > or = 2.5 kg
BMI: 10th - 90th percentile for age and gender
Ages 4.0 to 8.9 years
Ethnic distribution of greater Houston area
Usual calcium intake 600-1200 mg/d based on two 24-hour dietary recalls by phone
Any regularly taken (daily) vitamins and minerals must be stopped at least 1 month before starting the study

Exclusion Criteria:

History of any chronic illness.
Regularly taken (daily) medications (except seasonal allergies).
Avoidance of dairy products or meat in the diet.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868738

Locations

United States, Texas
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:

Steve Abrams, MD

Baylor College of Medicine

More Information

Additional Information:

USDA/ARS Children's Nutrition Research Center This link exits the ClinicalTrials.gov site

Publications:

Abrams SA, Griffin IJ, Hawthorne KM, Liang L, Gunn SK, Darlington G, Ellis KJ. A combination of prebiotic short- and long-chain inulin-type fructans enhances calcium absorption and bone mineralization in young adolescents. Am J Clin Nutr. 2005 Aug;82(2):471-6.

Abrams SA, Hawthorne KM, Aliu O, Hicks PD, Chen Z, Griffin IJ. An inulin-type fructan enhances calcium absorption primarily via an effect on colonic absorption in humans. J Nutr. 2007 Oct;137(10):2208-12.

Ames SK, Gorham BM, Abrams SA. Effects of high compared with low calcium intake on calcium absorption and incorporation of iron by red blood cells in small children. Am J Clin Nutr. 1999 Jul;70(1):44-8.

Beard JL, Dawson H, Piñero DJ. Iron metabolism: a comprehensive review. Nutr Rev. 1996 Oct;54(10):295-317. Review.

Bischoff-Ferrari HA, Dietrich T, Orav EJ, Dawson-Hughes B. Positive association between 25-hydroxy vitamin D levels and bone mineral density: a population-based study of younger and older adults. Am J Med. 2004 May 1;116(9):634-9. No abstract available.

Bray MS, Shaw CA, Moore MW, Garcia RA, Zanquetta MM, Durgan DJ, Jeong WJ, Tsai JY, Bugger H, Zhang D, Rohrwasser A, Rennison JH, Dyck JR, Litwin SE, Hardin PE, Chow CW, Chandler MP, Abel ED, Young ME. Disruption of the circadian clock within the cardiomyocyte influences myocardial contractile function, metabolism, and gene expression. Am J Physiol Heart Circ Physiol. 2008 Feb;294(2):H1036-47. Epub 2007 Dec 21.

Davidsson L, Ziegler EE, Kastenmayer P, Hurrell RF. Erythrocyte incorporation of iron by infants: iron bioavailability from a low-iron infant formula and an evaluation of the usefulness of correcting erythrocyte incorporation values, using a reference dose or plasma ferritin concentrations. Br J Nutr. 2000 Dec;84(6):847-53.

Donovan A, Andrews NC. The molecular regulation of iron metabolism. Hematol J. 2004;5(5):373-80. Review.

Eisenstein RS. Iron regulatory proteins and the molecular control of mammalian iron metabolism. Annu Rev Nutr. 2000;20:627-62. Review.

Fleet JC, Eksir F, Hance KW, Wood RJ. Vitamin D-inducible calcium transport and gene expression in three Caco-2 cell lines. Am J Physiol Gastrointest Liver Physiol. 2002 Sep;283(3):G618-25.

Fleet JC, Wood RJ. Specific 1,25(OH)2D3-mediated regulation of transcellular calcium transport in Caco-2 cells. Am J Physiol. 1999 Apr;276(4 Pt 1):G958-64.

Friend DR. Drug delivery to the small intestine. Curr Gastroenterol Rep. 2004 Oct;6(5):371-6. Review.

García-Casal MN, Leets I, Layrisse M. Beta-carotene and inhibitors of iron absorption modify iron uptake by Caco-2 cells. J Nutr. 2000 Jan;130(1):5-9.

Gordon CM, DePeter KC, Feldman HA, Grace E, Emans SJ. Prevalence of vitamin D deficiency among healthy adolescents. Arch Pediatr Adolesc Med. 2004 Jun;158(6):531-7.

Griffin IJ, Davila PM, Abrams SA. Non-digestible oligosaccharides and calcium absorption in girls with adequate calcium intakes. Br J Nutr. 2002 May;87 Suppl 2:S187-91.

Griffin IJ, Lynch MF, Hawthorne KM, Chen Z, Hamzo M, Abrams SA. Magnesium retention in 12 to 48 month-old children. J Am Coll Nutr. 2008 Apr;27(2):349-55.

Griffin IJ, Lynch MF, Hawthorne KM, Chen Z, Hamzo MG, Abrams SA. Zinc homeostasis in 1-4 year olds consuming diets typical of US children. Br J Nutr. 2007 Aug;98(2):358-63. Epub 2007 Apr 26.

Gunshin H, Allerson CR, Polycarpou-Schwarz M, Rofts A, Rogers JT, Kishi F, Hentze MW, Rouault TA, Andrews NC, Hediger MA. Iron-dependent regulation of the divalent metal ion transporter. FEBS Lett. 2001 Dec 7;509(2):309-16.

Hallberg L, Rossander L, Skånberg AB. Phytates and the inhibitory effect of bran on iron absorption in man. Am J Clin Nutr. 1987 May;45(5):988-96.

Heaney RP, Dowell MS, Hale CA, Bendich A. Calcium absorption varies within the reference range for serum 25-hydroxyvitamin D. J Am Coll Nutr. 2003 Apr;22(2):142-6.

Holick MF. Sunlight and vitamin D for bone health and prevention of autoimmune diseases, cancers, and cardiovascular disease. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1678S-88S. Review.

Johnston CC Jr, Miller JZ, Slemenda CW, Reister TK, Hui S, Christian JC, Peacock M. Calcium supplementation and increases in bone mineral density in children. N Engl J Med. 1992 Jul 9;327(2):82-7.

Lynch MF, Griffin IJ, Hawthorne KM, Chen Z, Hamzo M, Abrams SA. Calcium balance in 1-4-y-old children. Am J Clin Nutr. 2007 Mar;85(3):750-4.

Lynch SR. Iron overload: prevalence and impact on health. Nutr Rev. 1995 Sep;53(9):255-60. Review.

McKie AT, Barrow D, Latunde-Dada GO, Rolfs A, Sager G, Mudaly E, Mudaly M, Richardson C, Barlow D, Bomford A, Peters TJ, Raja KB, Shirali S, Hediger MA, Farzaneh F, Simpson RJ. An iron-regulated ferric reductase associated with the absorption of dietary iron. Science. 2001 Mar 2;291(5509):1755-9. Epub 2001 Feb 1.

Monsen ER. Iron nutrition and absorption: dietary factors which impact iron bioavailability. J Am Diet Assoc. 1988 Jul;88(7):786-90. Review.

Northstone K, Emmett P. Multivariate analysis of diet in children at four and seven years of age and associations with socio-demographic characteristics. Eur J Clin Nutr. 2005 Jun;59(6):751-60.

Rajakumar K, Fernstrom JD, Holick MF, Janosky JE, Greenspan SL. Vitamin D status and response to Vitamin D(3) in obese vs. non-obese African American children. Obesity (Silver Spring). 2008 Jan;16(1):90-5.

Thane CW, Bates CJ, Prentice A. Risk factors for low iron intake and poor iron status in a national sample of British young people aged 4-18 years. Public Health Nutr. 2003 Aug;6(5):485-96.

Vieth R, Bischoff-Ferrari H, Boucher BJ, Dawson-Hughes B, Garland CF, Heaney RP, Holick MF, Hollis BW, Lamberg-Allardt C, McGrath JJ, Norman AW, Scragg R, Whiting SJ, Willett WC, Zittermann A. The urgent need to recommend an intake of vitamin D that is effective. Am J Clin Nutr. 2007 Mar;85(3):649-50. No abstract available. Erratum in: Am J Clin Nutr. 2007 Sep;86(3):809.

Walczyk T, Davidsson L, Rossander-Hulthen L, Hallberg L, Hurrell RF. No enhancing effect of vitamin A on iron absorption in humans. Am J Clin Nutr. 2003 Jan;77(1):144-9.

Wessling-Resnick M. Iron transport. Annu Rev Nutr. 2000;20:129-51. Review.

Zoller H, Theurl I, Koch R, Kaser A, Weiss G. Mechanisms of iron mediated regulation of the duodenal iron transporters divalent metal transporter 1 and ferroportin 1. Blood Cells Mol Dis. 2002 Nov-Dec;29(3):488-97.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Abrams SA, Hawthorne KM, Chen Z. Supplementation with 1000 IU vitamin D/d leads to parathyroid hormone suppression, but not increased fractional calcium absorption, in 4-8-y-old children: a double-blind randomized controlled trial. Am J Clin Nutr. 2013 Jan;97(1):217-23. doi: 10.3945/ajcn.112.046102. Epub 2012 Nov 14.

Responsible Party:	Steve Abrams, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00868738 History of Changes
Other Study ID Numbers:	H-24134, 6250-51000-045-00D
Study First Received:	March 24, 2009
Last Updated:	November 1, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

Calcium
Vitamin D
Magnesium
Zinc

Additional relevant MeSH terms:

Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents

Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013