Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5 (VitD)
|ClinicalTrials.gov 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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- Height at the age of 3 years [ Time Frame: 3 years after the recruitment begins ]
- Bone densitometry by ultrasound [ Time Frame: 3 years after recruitment begins ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419821
|Contact: Avigdor Hevroni, MD||972508573982||Avigdor@hadassah.org.il|
|Clalit Health services||Not yet recruiting|
|Beitar Elit, Israel|
|Contact: Clalit 972-2-588-7000|
|Principal Investigator:||Avigdor Hevroni, MD||Hadassah Medical Center|