Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3 (Vitamin D RCT)

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital of Pittsburgh
Information provided by (Responsible Party):
Kumaravel Rajakumar, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00732758
First received: August 7, 2008
Last updated: November 30, 2015
Last verified: November 2015
  Purpose

The study objective is to characterize the threshold levels of serum 25-hydroxyvitamin D for the definition of vitamin D insufficiency in 8-14 year old African American and Caucasian children.

We propose a 6 month randomized placebo controlled trial of vitamin D (vitamin D3 1000 IU/day vs. placebo) initiated during October through March (during fall and winter) in 8 to 14 year old African American and Caucasian children. The results of the trial will help establish the cutoff threshold value of serum 25(OH)D for defining vitamin D insufficiency in preadolescent and adolescent children. Safety of vitamin D supplementation will be assessed by measuring serum calcium at 0, 2 and 6 months and by monitoring for adverse events. Currently recommended adequate intake for vitamin D of 200 IU daily may not meet the body's daily needs for vitamin D. Therefore, it is likely that a higher level of daily vitamin D intake may be needed to meet the body's skeletal and non-skeletal demands for vitamin D. Determining the dietary required intake of vitamin D for the prevention of vitamin D insufficiency during childhood has immense public health potential for addressing health disparities and ensuring better bone health during adulthood. The primary outcome measure will be serum 25(OH)D and parathyroid hormone (PTH). The secondary outcome measures will include: markers of bone formation (serum P1NP) and bone resorption (serum CTX).We will also examine differences in serum 25(OH)D, PTH, and markers of bone turnover in African American vs. Caucasian children.


Condition Intervention Phase
Healthy
Dietary Supplement: Vitamin D3 1000 IU
Dietary Supplement: Placebo Tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Serum 25-hydroxyvitamin D [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Circulating concentration of 25 hydroxyvitamin D is a biomarker of vitamin D status. Vitamin D deficiency was defined as serum 25-hydroxyvitamin D concentrations <20 ng/mL.


Secondary Outcome Measures:
  • Parathyroid Hormone (PTH) Dietary Data [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Osteocalcin (OC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Marker of bone formation

  • Collagen Type 1 Cross-linked C-telopeptide (CTx) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Collagen type 1 cross-linked C-telopeptide (CTx) is a marker of bone resorption.


Enrollment: 157
Study Start Date: October 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3
Vitamin D3 1000 IU Tablet
Dietary Supplement: Vitamin D3 1000 IU
Vitamin D3 1000 IU Tablet once daily for 6 months
Placebo Comparator: Placebo
Placebo Tablet
Dietary Supplement: Placebo Tablet
Placebo Tablet once daily for 6 months

Detailed Description:
Epidemiologic and clinical data document a high prevalence of vitamin D insufficiency among adults and adolescents in the US. Vitamin D insufficiency during childhood has the potential to impact the acquisition of peak bone mass. Vitamin D insufficiency is also associated with several non-skeletal disorders including cancer (prostate, breast, and colon), diabetes mellitus (type 1 and type 2), and multiple sclerosis. In our pilot study nearly 50% of 6 to 10 year old African American children residing in Pittsburgh, Pennsylvania, were deemed vitamin D insufficient (serum 25-hydroxyvitamin D (25(OH)D): ≤ 20 ng/mL; Rajakumar K, et al. Clinical Pediatrics. 2005;44:683-692). To extend this field further, we are proposing a randomized placebo-controlled trial of vitamin D3 for establishing the serum 25-hydroxyvitamin D (25(OH)D) cutoff threshold levels for defining vitamin D insufficiency during childhood and to document the safety and efficacy of treatment on the vitamin D status of the study cohort. A total of 168 (African American: 84, Caucasian: 84) 8 to 14 year old preadolescent and adolescent children will undergo a randomized-placebo controlled trial (RCT) of vitamin D3 1000 IU daily vs. placebo for 6 months initiated during fall and winter (October through March). Safety of vitamin D supplementation will be assessed by measuring serum calcium at 0, 2 and 6 months and by monitoring for adverse events. We will also examine the differences in serum 25(OH)D, PTH, and markers of bone turnover in African American vs. Caucasian children. The primary outcome measure will be serum 25(OH)D and PTH. The secondary outcome measures will include: markers of bone formation: serum osteocalcin (OC) and bone resorption: serum C-terminal cross-linking telopeptide of type 1 collagen (serum CTX). Additional outcomes will include: dietary intake of vitamin D and calcium, skin color (Fitzpatrick Sunreactive Skin Type and Melanin Index), sun exposure, and body mass index. Vitamin D deficiency will be defined as serum 25-hydroxyvitamin D concentrations <20 ng/mL. Public health importance of childhood vitamin D insufficiency is linked to the impact of vitamin D status on the acquisition of peak bone mass. Reduced peak bone mass can predispose to premature onset of osteoporosis and increase the risk for osteoporosis related fragility fractures. Achieving and maintaining vitamin D sufficiency during childhood can positively impact the skeletal health of children and reduce their "osteoporosis" burden during adulthood, and modify their risk for the non-skeletal disorders associated with chronic vitamin D insufficiency. Paucity of data regarding threshold levels of serum 25(OH)D associated with vitamin D insufficiency status among school age children and the likelihood that the serum 25(OH)D threshold levels for vitamin D sufficiency could be different among African American and Caucasian children makes it compelling for this issue to be explored. Based on expert opinion and supportive data in the medical literature, we feel that the currently recommended adequate intake for vitamin D for pre- and adolescent children (200 IU daily) is woefully inadequate to meet the daily needs for vitamin D. Therefore, it is likely that a higher level of daily vitamin D intake may be needed to meet the body's skeletal and non-skeletal demands for vitamin D. This study will determine the serum 25(OH)D cutoff for the definition of vitamin D insufficiency and document the safety and efficacy of treatment on vitamin D status.
  Eligibility

Ages Eligible for Study:   8 Years to 14 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 8-14 years
  • Race: African American or Caucasian
  • Children not taking multivitamins for at least 1 month before enrollment and agree not to start any multivitamin supplements during the 6-month trial period.
  • Children who are on multivitamins can be considered for enrollment only if they are able to and agree to stop their multivitamin tablet for a 1 month washout period prior to enrollment.
  • Absence of chronic diseases that could affect growth or calcium or vitamin D metabolism

Exclusion Criteria:

  • Hepatic or renal disease
  • Metabolic rickets
  • Malabsorptive disorders (Crohn's disease, cystic fibrosis and celiac disease) or cancer
  • Treatment with anticonvulsants or systemic glucocorticoids
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00732758

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15217
Sponsors and Collaborators
University of Pittsburgh
Children's Hospital of Pittsburgh
Investigators
Principal Investigator: Kumaravel Rajakumar, MD University of Pittsburgh
  More Information

Publications:
Responsible Party: Kumaravel Rajakumar, Associate Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00732758     History of Changes
Other Study ID Numbers: 1K23HD052550-01A2 
Study First Received: August 7, 2008
Results First Received: September 22, 2015
Last Updated: November 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Vitamin D Deficiency
Vitamin D Insufficiency
Child
Adolescent
African American
Caucasian
Definition
Preadolescent

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 22, 2016