NCT00697294

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 5, 2011

Status Verified

December 1, 2011

Enrollment Period

3 years

First QC Date

June 3, 2008

Last Update Submit

December 2, 2011

Conditions

Vitamin D Deficiency

Keywords

Vitamin D deficiencyInfantsBreast feeding

Outcome Measures

Primary Outcomes (1)

  • To evaluate the relative frequency of vitamin D deficiency in human milk fed Hispanic compared to Caucasian newborn infants in Houston, Texas.

    End of study

Secondary Outcomes (2)

  • To determine if infant vitamin D status is related to bone mineral status at birth

    End of study

  • 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.

    End of study

Study Arms (1)

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

Interventions

Tri-Vi-SolDIETARY_SUPPLEMENT

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.

Also known as: ADC drops
Supplement

Eligibility Criteria

AgeUp to 2 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Insufficient cord blood available to determine cord 25-hydroxyvitamin D status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

St Lukes Episcopal Hospital

Houston, Texas, 77030, United States

Location

Related Publications (20)

  • Shah M, Salhab N, Patterson D, Seikaly MG. Nutritional rickets still afflict children in north Texas. Tex Med. 2000 Jun;96(6):64-8.

    PMID: 10876374BACKGROUND

  • Javaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 Jan 7;367(9504):36-43. doi: 10.1016/S0140-6736(06)67922-1.

    PMID: 16399151BACKGROUND

  • McGrath J. Does 'imprinting' with low prenatal vitamin D contribute to the risk of various adult disorders? Med Hypotheses. 2001 Mar;56(3):367-71. doi: 10.1054/mehy.2000.1226.

    PMID: 11359362BACKGROUND

  • Basile LA, Taylor SN, Wagner CL, Quinones L, Hollis BW. Neonatal vitamin D status at birth at latitude 32 degrees 72': evidence of deficiency. J Perinatol. 2007 Sep;27(9):568-71. doi: 10.1038/sj.jp.7211796. Epub 2007 Jul 12.

    PMID: 17625571BACKGROUND

  • Dijkstra SH, van Beek A, Janssen JW, de Vleeschouwer LH, Huysman WA, van den Akker EL. High prevalence of vitamin D deficiency in newborn infants of high-risk mothers. Arch Dis Child. 2007 Sep;92(9):750-3. doi: 10.1136/adc.2006.105577.

    PMID: 17715438BACKGROUND

  • Lee JM, Smith JR, Philipp BL, Chen TC, Mathieu J, Holick MF. Vitamin D deficiency in a healthy group of mothers and newborn infants. Clin Pediatr (Phila). 2007 Jan;46(1):42-4. doi: 10.1177/0009922806289311.

    PMID: 17164508BACKGROUND

  • Brunvand L, Haga P, Tangsrud SE, Haug E. Congestive heart failure caused by vitamin D deficiency? Acta Paediatr. 1995 Jan;84(1):106-8. doi: 10.1111/j.1651-2227.1995.tb13499.x.

    PMID: 7734890BACKGROUND

  • Brooke OG, Butters F, Wood C. Intrauterine vitamin D nutrition and postnatal growth in Asian infants. Br Med J (Clin Res Ed). 1981 Oct 17;283(6298):1024. doi: 10.1136/bmj.283.6298.1024. No abstract available.

    PMID: 6794748BACKGROUND

  • Cockburn F, Belton NR, Purvis RJ, Giles MM, Brown JK, Turner TL, Wilkinson EM, Forfar JO, Barrie WJ, McKay GS, Pocock SJ. Maternal vitamin D intake and mineral metabolism in mothers and their newborn infants. Br Med J. 1980 Jul 5;281(6232):11-4. doi: 10.1136/bmj.281.6232.11.

    PMID: 7407476BACKGROUND

  • Alfaham M, Woodhead S, Pask G, Davies D. Vitamin D deficiency: a concern in pregnant Asian women. Br J Nutr. 1995 Jun;73(6):881-7. doi: 10.1079/bjn19950093.

    PMID: 7632669BACKGROUND

  • Datta S, Alfaham M, Davies DP, Dunstan F, Woodhead S, Evans J, Richards B. Vitamin D deficiency in pregnant women from a non-European ethnic minority population--an interventional study. BJOG. 2002 Aug;109(8):905-8. doi: 10.1111/j.1471-0528.2002.01171.x.

    PMID: 12197370BACKGROUND

  • 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. doi: 10.1080/07315724.1999.10718839.

    PMID: 10204827BACKGROUND

  • 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. doi: 10.1111/j.1442-200x.2005.02141.x.

    PMID: 16354218BACKGROUND

  • 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. doi: 10.1007/s00223-006-0007-5. Epub 2006 Jul 7.

    PMID: 16830197BACKGROUND

  • 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. doi: 10.1093/jn/129.3.666.

    PMID: 10082772BACKGROUND

  • 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. doi: 10.1002/jbmr.5650050105.

    PMID: 2309575BACKGROUND

  • 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. doi: 10.1359/jbmr.1997.12.11.1761.

    PMID: 9383679BACKGROUND

  • Zadshir A, Tareen N, Pan D, Norris K, Martins D. The prevalence of hypovitaminosis D among US adults: data from the NHANES III. Ethn Dis. 2005 Autumn;15(4 Suppl 5):S5-97-101.

    PMID: 16315387BACKGROUND

  • 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. doi: 10.1515/jpem.2006.19.8.1025.

    PMID: 16995588BACKGROUND

  • Abrams SA, Hawthorne KM, Rogers SP, Hicks PD, Carpenter TO. Effects of ethnicity and vitamin D supplementation on vitamin D status and changes in bone mineral content in infants. BMC Pediatr. 2012 Jan 16;12:6. doi: 10.1186/1471-2431-12-6.

    PMID: 22248486DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyBreast Feeding

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Study Officials

  • Steven A Abrams, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 13, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2011

Study Completion

November 1, 2011

Last Updated

December 5, 2011

Record last verified: 2011-12

Locations

US(3)