NCT01050387

Brief Summary

The purpose of this study is to determine if the vitamin D binding protein genotype influences circulating vitamin D levels and if it may have functional consequences on vitamin D activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 5, 2014

Status Verified

July 1, 2013

Enrollment Period

3.1 years

First QC Date

January 13, 2010

Last Update Submit

August 2, 2014

Conditions

Vitamin D Deficiency

Keywords

Vitamin D DeficiencyVDDVitamin D SupplementationVitamin D Binding ProteinDBPNutritional ricketsrickets25hydroxyvitamin D25OHD1,25OH2Dvitamin D metabolitesPTHvitamin D homeostasis

Outcome Measures

Primary Outcomes (1)

  • Changes in serum 25-OH vitamin D

    6 months

Interventions

Vitamin DDIETARY_SUPPLEMENT

Vitamin D (either 400 IU vs 1000 IU) given orally each day

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • months to 6 years of age
  • healthy or free from any diseases or conditions that may affect nutritional status or bone metabolism
  • willingness of family to participate in a 6-month study of vitamin D supplementation

You may not qualify if:

  • Chronic disease
  • Prematurity \< 32 weeks gestational age
  • Liver disease such as hepatitis or renal/urologic disease (e.g., recurrent urinary tract infection)
  • Use of pharmacologic or prescription-level dosages of vitamin D or its metabolites. We will exclude users of any systemic glucocorticoid preparation and users of inhaled steroids that are considered greater than medium dose for age 4 yrs. Specifically, this would exclude users of over 1 mg/day of budesonide, and over 352 mcg/day of fluticasone.
  • Current or recent (within 1 month) use of anticonvulsants or other medications known to affect bone and mineral homeostasis or alkaline phosphatase levels.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (7)

  • Gungor N, Saad R, Janosky J, Arslanian S. Validation of surrogate estimates of insulin sensitivity and insulin secretion in children and adolescents. J Pediatr. 2004 Jan;144(1):47-55. doi: 10.1016/j.jpeds.2003.09.045.

    PMID: 14722518BACKGROUND

  • DeLucia MC, Mitnick ME, Carpenter TO. Nutritional rickets with normal circulating 25-hydroxyvitamin D: a call for reexamining the role of dietary calcium intake in North American infants. J Clin Endocrinol Metab. 2003 Aug;88(8):3539-45. doi: 10.1210/jc.2002-021935.

    PMID: 12915633BACKGROUND

  • Heaney RP, Davies KM, Chen TC, Holick MF, Barger-Lux MJ. Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am J Clin Nutr. 2003 Jan;77(1):204-10. doi: 10.1093/ajcn/77.1.204.

    PMID: 12499343BACKGROUND

  • Safadi FF, Thornton P, Magiera H, Hollis BW, Gentile M, Haddad JG, Liebhaber SA, Cooke NE. Osteopathy and resistance to vitamin D toxicity in mice null for vitamin D binding protein. J Clin Invest. 1999 Jan;103(2):239-51. doi: 10.1172/JCI5244.

    PMID: 9916136BACKGROUND

  • Zella LA, Shevde NK, Hollis BW, Cooke NE, Pike JW. Vitamin D-binding protein influences total circulating levels of 1,25-dihydroxyvitamin D3 but does not directly modulate the bioactive levels of the hormone in vivo. Endocrinology. 2008 Jul;149(7):3656-67. doi: 10.1210/en.2008-0042. Epub 2008 Mar 27.

    PMID: 18372326BACKGROUND

  • Pettifor JM. Nutritional Rickets. In: Pediatric Bone: Biology and Diseases. Glorieux FH, Pettifor JM, Juppner H (eds.) Academic Press: San Diego, CA, p 541-565, 2003.

    BACKGROUND

  • Simpson CA, Zhang JH, Vanderschueren D, Fu L, Pennestri TC, Bouillon R, Cole DEC, Carpenter TO. Relationship of Total and Free 25-Hydroxyvitamin D to Biomarkers and Metabolic Indices in Healthy Children. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1631-40. doi: 10.1210/clinem/dgz230.

    PMID: 31774125DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyRickets

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesCalcium Metabolism Disorders

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Thomas O Carpenter, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 15, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 5, 2014

Record last verified: 2013-07

Locations

US(1)