Impact of Vitamin D Status on Bones in Breastfed Infants - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00697294

Purpose

Vitamin D deficiency is widespread and linked to decreased bone mineral content. Little data exists regarding the vitamin D status and the relationship of 25-hydroxyvitamin D (25-OHD) status to functional bone health outcomes in Hispanic infants. To evaluate this, we plan an observational cohort of full term, healthy, exclusively breastfed Hispanic and Caucasian infants. We hypothesize serum 25-OHD measured in cord blood will be significantly lower in Hispanic than Caucasian infants, with 25-OHD less than 20 ng/mL found in at least 50% of Hispanic neonates. Secondary aims evaluate the relationship between 25-OHD levels and bone mineral status at baseline and after 3 months of 400 IU/day supplemental vitamin D3. Whole body bone density scan (DXA) and bone ultrasound (SOS U/S) will be measured shortly after birth, then again after supplementation. Data from this study will provide information needed to design further randomized trials and interventions.

Condition	Intervention
Vitamin D Deficiency	Dietary Supplement: Tri-Vi-Sol

MedlinePlus related topics: Breast Feeding Minerals

Drug Information available for: Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Vitamin D Status and Impact on Bone Mineralization in Human Milk Fed Hispanic and Caucasian Infants

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

To evaluate the relative frequency of vitamin D deficiency in human milk fed Hispanic compared to Caucasian newborn infants in Houston, Texas. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if infant vitamin D status is related to bone mineral status at birth [ Time Frame: End of study ] [ Designated as safety issue: No ]
To determine the effects of vitamin D supplementation on 25-hydroxyvitamin D (25-OHD) concentration and bone mineral status vitamin D deficient and vitamin D replete infants at 3 months of age. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Supplement: Experimental Subjects will serve as their own control in this single-arm protocol. All subjects will receive 400 IU/day of vitamin D as the intervention. Comparisons will be made between Caucasian and Hispanic infants.	Dietary Supplement: Tri-Vi-Sol All subjects will begin vitamin D supplementation at the first outpatient visit (at 1 week of life) and will continue through the second outpatient visit (at 3 months of age). Dosage will be 400 IU/day of vitamin D in the form of Tri-Vi-Sol vitamin drops.

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 2 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Full term infants (37-42 weeks)
Appropriate for gestational age
Free of major congenital anomalies
Born to mothers without a history of diabetes or chronic illness who intend to exclusively breastfeed

Exclusion Criteria:

Any child who does not meet the above inclusion criteria
Insufficient cord blood available to determine cord 25-hydroxyvitamin D status

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697294

Contacts

Contact: Stefanie P Rogers, MD	713-798-6707	spr@bcm.edu
Contact: Keli M Hawthorne, MS, RD	713-798-7085	kelih@bcm.edu

Locations

United States, Texas
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Stefanie P Rogers, MD 713-798-6707 spr@bcm.edu
Contact: Keli M Hawthorne, MS, RD 713-798-7085 kelih@bcm.edu
Principal Investigator: Steven A Abrams, MD
Sub-Investigator: Stefanie P Rogers, MD
Sub-Investigator: Keli M Hawthorne, MS, RD
Ben Taub General Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Stefanie Rogers, MD 713-798-6707 spr@bcm.edu
St Lukes Episcopal Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Stefanie Rogers, MD 713-798-6707 spr@bcm.edu

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:

Steven A Abrams, MD

Baylor College of Medicine

More Information

Publications:

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Waiters B, Godel JC, Basu TK. Perinatal vitamin D and calcium status of northern Canadian mothers and their newborn infants. J Am Coll Nutr. 1999 Apr;18(2):122-6.

Molla AM, Al Badawi M, Hammoud MS, Molla AM, Shukkur M, Thalib L, Eliwa MS. Vitamin D status of mothers and their neonates in Kuwait. Pediatr Int. 2005 Dec;47(6):649-52.

Nicolaidou P, Hatzistamatiou Z, Papadopoulou A, Kaleyias J, Floropoulou E, Lagona E, Tsagris V, Costalos C, Antsaklis A. Low vitamin D status in mother-newborn pairs in Greece. Calcif Tissue Int. 2006 Jun;78(6):337-42. Epub 2006 Jul 7.

Abrams SA, Copeland KC, Gunn SK, Stuff JE, Clarke LL, Ellis KJ. Calcium absorption and kinetics are similar in 7- and 8-year-old Mexican-American and Caucasian girls despite hormonal differences. J Nutr. 1999 Mar;129(3):666-71.

Reasner CA 2nd, Dunn JF, Fetchick DA, Liel Y, Hollis BW, Epstein S, Shary J, Mundy GR, Bell NH. Alteration of vitamin D metabolism in Mexican-Americans. J Bone Miner Res. 1990 Jan;5(1):13-7.

Looker AC, Orwoll ES, Johnston CC Jr, Lindsay RL, Wahner HW, Dunn WL, Calvo MS, Harris TB, Heyse SP. Prevalence of low femoral bone density in older U.S. adults from NHANES III. J Bone Miner Res. 1997 Nov;12(11):1761-8.

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Ashraf A, Mick G, Atchison J, Petrey B, Abdullatif H, McCormick K. Prevalence of hypovitaminosis D in early infantile hypocalcemia. J Pediatr Endocrinol Metab. 2006 Aug;19(8):1025-31.

Responsible Party:	Baylor College of Medicine ( Steve Abrams, MD )
Study ID Numbers:	H-22293
Study First Received:	June 3, 2008
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00697294
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

Vitamin D deficiency
Infants
Breast feeding

Study placed in the following topic categories:

Vitamin D Deficiency
Vitamin D
Malnutrition
Avitaminosis

Ergocalciferols
Nutrition Disorders
Deficiency Diseases

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009