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

NCT00732758 | Completed Phase 1 Results

• 1 other identifier: 1K23HD052550-01A2
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Vitamin D Deficiency; Vitamin D Insufficiency; Child; Adolescent; African American; Caucasian; Definition; Preadolescent

Outcome Measures

Primary Outcomes (1)

• Serum 25-hydroxyvitamin D

  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.

  6 months

Secondary Outcomes (3)

• Parathyroid Hormone (PTH) Dietary Data

  6 months

• Osteocalcin (OC)

  6 months

• Collagen Type 1 Cross-linked C-telopeptide (CTx)

  6 months

Study Arms (2)

Vitamin D3

EXPERIMENTAL

Vitamin D3 1000 IU Tablet

Dietary Supplement: Vitamin D3 1000 IU

Placebo

PLACEBO COMPARATOR

Placebo Tablet

Dietary Supplement: Placebo Tablet

Interventions

Vitamin D3 1000 IU DIETARY_SUPPLEMENT

Vitamin D3 1000 IU Tablet once daily for 6 months

Vitamin D3

Placebo Tablet DIETARY_SUPPLEMENT

Placebo Tablet once daily for 6 months

Placebo

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Hepatic or renal disease
• Metabolic rickets
• Malabsorptive disorders (Crohn's disease, cystic fibrosis and celiac disease) or cancer
• Treatment with anticonvulsants or systemic glucocorticoids

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15217, United States

Location

Related Publications (1)

• Rajakumar K, Moore CG, Yabes J, Olabopo F, Haralam MA, Comer D, Bogusz J, Nucci A, Sereika S, Dunbar-Jacob J, Holick MF, Greenspan SL. Effect of Vitamin D3 Supplementation in Black and in White Children: A Randomized, Placebo-Controlled Trial. J Clin Endocrinol Metab. 2015 Aug;100(8):3183-92. doi: 10.1210/jc.2015-1643. Epub 2015 Jun 19.

  PMID: 26091202 RESULT

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

No limitations.

Results Point of Contact

• Title: Kumaravel Rajakumar
• Organization: Children's Hospital of Pittsburgh

rajakumark@upmc.edu

412-692-5822

Study Officials

• Kumaravel Rajakumar, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 12, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 29, 2015
• Results First Posted: October 22, 2015

Record last verified: 2015-11

Locations

US (1)