Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5 (VitD)

February 21, 2013 updated by: Meir Medical Center

Supplemental Vitamin D Administered to One Year Old Vitamin D Deficient Infants Until Age 3 and Its Affect on Growth Rates and Bone Mineral Density Until Age 5

Abstract Background: Vitamin D affects a wide variety of functions in the body including regulation of calcium, phosphorus, and bone metabolism. Israeli studies have documented a high prevalence of Vitamin D deficiency in Israeli infants in general, which was more severe in infants from Ultra-Orthodox Jewish families. Modest dress requirements in this population drastically reduce sun exposure, known to encourage production of Vitamin D. Countless research has analyzed preterm as well as term neonates born to mothers with vitamin D deficiency, with regard to weight, height, and bone mineral density at birth. However, there is a paucity of information about healthy infants' vitamin D levels and its' correlation to these parameters during the first few years of life. Objectives: The purpose of the proposed study is to measure and correlate levels of 25(OH)D and bone mineral density towards the end of the first year of life with growth rates and bone mineral density in the same children at the ages of 2, 3 and 5 years. Patients and Methods: The study will be performed in the Ultra-Orthodox Jewish community of Beitar Illit. 25(OH)D levels will be taken between 9-12 months of age (when routine blood tests are normally drawn for these infants) and bone mineral density will be measured using Quantitative Ultrasound. Infants will be divided into 2 groups: those with those with normal 25(OH)D levels (>15ng/ml), and those with 25(OH)D deficiency (<15ng/ml). Group 1- normal levels will receive no intervention. Infants with 25(OH)D below 15ng/ml will be randomly assigned into one of two groups; Group 2-those receiving continued vitamin D supplementation of 800 international units(IU) (4gtt/d) for one year, or Group 3- those receiving the placebo. Height, weight, and head circumference growth curves will be recorded every two months until 2 years of age. Quantitative ultrasound, growth charts and blood tests including 25(OH)D, serum calcium and phosphate levels, Parathyroid hormone (PTH), and alkaline phosphatase, taken at approximately 9-12 months will be repeated at 2 years of age. At that time children from Group 1 (no supplementation) will be divided into three: Group 1a- normal 25(OH)D levels will continue with no intervention, Group 1b <15ng/ml will begin receiving vitamin D 4gtt/d, Group 1c <15ng/ml will receive a placebo until age three. Groups 2 and 3 will continue their previous treatment until age three. All aforementioned tests will be repeated at age 3, when treatment will stop, and the same tests will be repeated at age 5.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beitar Elit, Israel
        • Clalit health services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Infants between 9-12 months old in Tipat Chalav and Kupat Holim Clalit in Beitar Illit undergoing a blood draw for CBC at one year of age.

Exclusion Criteria:

Parents that refuse to participate in this study, infants with any diagnosed chronic disease, and preterm infants less than 34 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vit D supplementation
Group 2-Infants with 25(OH)D below 15ng/ml receiving continued vitamin D supplementation of 800IU (4gtt/d) for one year.
Drug: Vitamin D
800IU (4gtt/d) once a day for 2 years once a day.
Other Names:
  • TipTipot Vitamin D 200IU/gtt
Placebo Comparator: Placebo group
Group 3- Infants with 25(OH)D below 15ng/ml those receiving the placebo.
Other: Placebo (for Vitamin D)
4gtt/d for the placebo for two years.
No Intervention: Normal group
Group 1- infants with 25(OH)D above 15ng/ml (normal levels) will receive no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Height at the age of 3 years
Time Frame: 3 years after the recruitment begins
3 years after the recruitment begins

Secondary Outcome Measures

Outcome Measure
Time Frame
Bone densitometry by ultrasound
Time Frame: 3 years after recruitment begins
3 years after recruitment begins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Avigdor Hevroni, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (Estimate)

August 18, 2011

Study Record Updates

Last Update Posted (Estimate)

February 22, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protocol 5.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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