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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2011 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01419821
First received: August 17, 2011
Last updated: February 21, 2013
Last verified: August 2011
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Drug: Vitamin D
Other: Placebo (for Vitamin D)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Height at the age of 3 years [ Time Frame: 3 years after the recruitment begins ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone densitometry by ultrasound [ Time Frame: 3 years after recruitment begins ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   9 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  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: NCT01419821

Contacts
Contact: Avigdor Hevroni, MD 972508573982 Avigdor@hadassah.org.il

Locations
Israel
Clalit Health services Not yet recruiting
Beitar Elit, Israel
Contact: Clalit    972-2-588-7000      
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Avigdor Hevroni, MD Hadassah Medical Center
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01419821     History of Changes
Other Study ID Numbers: protocol 5.3
Study First Received: August 17, 2011
Last Updated: February 21, 2013
Health Authority: Israel: Clalit Health Services
Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Vitamin D
Bone densitometry
Vitamin D supplementation
Growth

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 20, 2014