Evaluation of Calcium, Vitamin D, Magnesium, and Zinc Absorption in Children

NCT00868738 | Completed

• 2 other identifiers: H-241346250-51000-045-00D
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mineral Absorption

Keywords

Calcium; Vitamin D; Magnesium; Zinc

Outcome Measures

Primary Outcomes (1)

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

  End of the study

Secondary Outcomes (1)

• Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of age.

  End of the study

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Vitamin D DIETARY_SUPPLEMENT

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; Vitamin D

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (36)

• 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. doi: 10.1093/ajcn.82.2.471.

  PMID: 16087995 BACKGROUND

• 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. doi: 10.1093/jn/137.10.2208.

  PMID: 17884999 BACKGROUND

• 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. doi: 10.1093/ajcn/70.1.44.

  PMID: 10393137 BACKGROUND

• Beard JL, Dawson H, Pinero DJ. Iron metabolism: a comprehensive review. Nutr Rev. 1996 Oct;54(10):295-317. doi: 10.1111/j.1753-4887.1996.tb03794.x.

  PMID: 9063021 BACKGROUND

• 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. doi: 10.1016/j.amjmed.2003.12.029. No abstract available.

  PMID: 15093761 BACKGROUND

• 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. doi: 10.1152/ajpheart.01291.2007. Epub 2007 Dec 21.

  PMID: 18156197 BACKGROUND

• 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.

  PMID: 11177201 BACKGROUND

• Donovan A, Andrews NC. The molecular regulation of iron metabolism. Hematol J. 2004;5(5):373-80. doi: 10.1038/sj.thj.6200540.

  PMID: 15448662 BACKGROUND

• Eisenstein RS. Iron regulatory proteins and the molecular control of mammalian iron metabolism. Annu Rev Nutr. 2000;20:627-62. doi: 10.1146/annurev.nutr.20.1.627.

  PMID: 10940348 BACKGROUND

• 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. doi: 10.1152/ajpgi.00269.2001.

  PMID: 12181175 BACKGROUND

• 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):G958-64. doi: 10.1152/ajpgi.1999.276.4.G958.

  PMID: 10198340 BACKGROUND

• Friend DR. Drug delivery to the small intestine. Curr Gastroenterol Rep. 2004 Oct;6(5):371-6. doi: 10.1007/s11894-004-0052-z.

  PMID: 15341712 BACKGROUND

• Garcia-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. doi: 10.1093/jn/130.1.5.

  PMID: 10613757 BACKGROUND

• 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. doi: 10.1001/archpedi.158.6.531.

  PMID: 15184215 BACKGROUND

• 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. doi: 10.1079/BJNBJN/2002536.

  PMID: 12088517 BACKGROUND

• 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. doi: 10.1080/07315724.2008.10719711.

  PMID: 18689570 BACKGROUND

• 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. doi: 10.1017/S0007114507708796. Epub 2007 Apr 26.

  PMID: 17459190 BACKGROUND

• 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. doi: 10.1016/s0014-5793(01)03189-1.

  PMID: 11741608 BACKGROUND

• Hallberg L, Rossander L, Skanberg AB. Phytates and the inhibitory effect of bran on iron absorption in man. Am J Clin Nutr. 1987 May;45(5):988-96. doi: 10.1093/ajcn/45.5.988.

  PMID: 3034044 BACKGROUND

• 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. doi: 10.1080/07315724.2003.10719287.

  PMID: 12672710 BACKGROUND

• 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. doi: 10.1093/ajcn/80.6.1678S.

  PMID: 15585788 BACKGROUND

• 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. doi: 10.1056/NEJM199207093270204.

  PMID: 1603140 BACKGROUND

• 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. doi: 10.1093/ajcn/85.3.750.

  PMID: 17344496 BACKGROUND

• Lynch SR. Iron overload: prevalence and impact on health. Nutr Rev. 1995 Sep;53(9):255-60. doi: 10.1111/j.1753-4887.1995.tb05482.x.

  PMID: 8577408 BACKGROUND

• 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. doi: 10.1126/science.1057206. Epub 2001 Feb 1.

  PMID: 11230685 BACKGROUND

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

  PMID: 3290310 BACKGROUND

• 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. doi: 10.1038/sj.ejcn.1602136.

  PMID: 15841093 BACKGROUND

• 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. doi: 10.1038/oby.2007.23.

  PMID: 18223618 BACKGROUND

• 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. doi: 10.1079/PHN2002455.

  PMID: 12943565 BACKGROUND

• 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. doi: 10.1093/ajcn/85.3.649. No abstract available.

  PMID: 17344484 BACKGROUND

• 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. doi: 10.1093/ajcn/77.1.144.

  PMID: 12499334 BACKGROUND

• Wessling-Resnick M. Iron transport. Annu Rev Nutr. 2000;20:129-51. doi: 10.1146/annurev.nutr.20.1.129.

  PMID: 10940329 BACKGROUND

• 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. doi: 10.1006/bcmd.2002.0587.

  PMID: 12547239 BACKGROUND

• Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

  PMID: 33305842 DERIVED

• Cummings SR, Eastell R. A History of Pivotal Advances in Clinical Research into Bone and Mineral Diseases. J Bone Miner Res. 2018 Jan;33(1):5-12. doi: 10.1002/jbmr.3353. Epub 2018 Jan 12. No abstract available.

  PMID: 29329487 DERIVED

• 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.

  PMID: 23151536 DERIVED

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Steve Abrams, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 2, 2011

Record last verified: 2011-11

Locations

US (1)