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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Yale University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Thrasher Research Fund
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01050387
First received: January 13, 2010
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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 Intervention
Vitamin D Deficiency
Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Changes in serum 25-OH vitamin D [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Vitamin D
    Vitamin D (either 400 IU vs 1000 IU) given orally each day
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.

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050387

Contacts
Contact: Elizabeth A Olear, M.S., M.A 203-785-3759 elizabeth.olear@yale.edu
Contact: Teri Tuma 203-785-2215 teri.tuma@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Thomas O Carpenter, M.D.         
Sponsors and Collaborators
Yale University
Thrasher Research Fund
Investigators
Principal Investigator: Thomas O Carpenter, M.D. Yale University
  More Information

Publications:
Responsible Party: Thomas O. Carpenter, M.D., Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT01050387     History of Changes
Other Study ID Numbers: 0909005699, 1RC1HD063562, M#136410
Study First Received: January 13, 2010
Last Updated: January 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Nutritional rickets
rickets
Vitamin D Deficiency
VDD
Vitamin D Supplementation
Vitamin D Binding Protein
DBP
25hydroxyvitamin D
25OHD
1,25OH2D
vitamin D metabolites
PTH
vitamin D homeostasis

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 23, 2014