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Effects of Vitamin D Dose and Genotype of the Binding Protein in Infants and Children (VitaD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01050387
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : August 5, 2014
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Thrasher Research Fund
Information provided by (Responsible Party):
Thomas Carpenter, Yale University

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Vitamin D Not Applicable

Detailed Description:

Vitamin D has recently been the subject of much attention. Advantages to the prevention of vitamin D deficiency (VDD) in young children are obvious: acutely, hypocalcemic seizures may occur in VDD, and rickets can result in long-term skeletal deformities. Previous research has emphasized the importance of identifying optimal supplementation doses and appropriate target thresholds for circulating 25-hydroxyvitamin D (25-OHD), the best described marker of vitamin D status. The timely next step is to objectively establish effective doses for the prevention of VDD, without creating risk from overzealous supplementation, in a population representative of those most at risk for overt disease.

Although the primary role of vitamin D is considered to be its effect on intestinal calcium absorption, enormous variability of fractional calcium absorption in relation to 25-OHD levels exists. We provide evidence that a significant component of this variability is genetic in nature and in particular, relates to vitamin D binding protein (DBP) genotype.

The aggregate data suggest that the critical mechanism for the development of nutritional rickets is reduction in availability of calcium to the skeleton, which is largely determined by vitamin D status and intestinal calcium absorption. Our proposal focuses on the establishment of a workable definition of vitamin D deficiency in an underserved and highly vulnerable population and to assess the impact of genetic variance in VDR and DBP as factors to be considered in the recommendation of vitamin D status assessment, taking into account the outcome of 25-OHD level, and in additional studies, potential functional consequences of vitamin D related to both its classical and non-classical effects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of Vitamin D Supplementation in Infants and Children: Effects of Vitamin D Dose and Genotype of the Binding Protein
Study Start Date : January 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Intervention Details:
  • Dietary Supplement: Vitamin D
    Vitamin D (either 400 IU vs 1000 IU) given orally each day

Primary Outcome Measures :
  1. Changes in serum 25-OH vitamin D [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 6 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01050387

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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Thrasher Research Fund
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Principal Investigator: Thomas O Carpenter, M.D. Yale University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Thomas Carpenter, Professor, Yale University Identifier: NCT01050387    
Other Study ID Numbers: 0909005699
1RC1HD063562 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: July 2013
Keywords provided by Thomas Carpenter, Yale University:
Vitamin D Deficiency
Vitamin D Supplementation
Vitamin D Binding Protein
Nutritional rickets
25hydroxyvitamin D
vitamin D metabolites
vitamin D homeostasis
Additional relevant MeSH terms:
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Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents