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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01419821
Recruitment Status : Unknown
Verified August 2011 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 18, 2011
Last Update Posted : February 22, 2013
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Vitamin D Other: Placebo (for Vitamin D) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

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 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.

Primary Outcome Measures :
  1. Height at the age of 3 years [ Time Frame: 3 years after the recruitment begins ]

Secondary Outcome Measures :
  1. Bone densitometry by ultrasound [ Time Frame: 3 years after recruitment begins ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   9 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01419821

Contact: Avigdor Hevroni, MD 972508573982

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

Responsible Party: Meir Medical Center Identifier: NCT01419821     History of Changes
Other Study ID Numbers: protocol 5.3
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: August 2011

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

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents