Vitamin D DeficiencyVitDNCT01419821
Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5
A study testing Vitamin D in people with Vitamin D Deficiency, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Parents that refuse to participate in this study, infants with any diagnosed chronic disease, and preterm infants less than 34 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D, Placebo (for Vitamin D)
- Keywords
- Vitamin D, Bone densitometry, Vitamin D supplementation, Growth
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called TipTipot Vitamin D 200IU/gtt
800IU (4gtt/d) once a day for 2 years once a day.
Placebo (for Vitamin D)Other
4gtt/d for the placebo for two years.
| Study group | Role | What they receive |
|---|---|---|
| Vit D supplementation | Active comparator | Group 2-Infants with 25(OH)D below 15ng/ml receiving continued vitamin D supplementation of 800IU (4gtt/d) for one year. Receives: Drug: Vitamin D |
| Placebo group | Placebo comparator | Group 3- Infants with 25(OH)D below 15ng/ml those receiving the placebo. Receives: Other: Placebo (for Vitamin D) |
| Normal group | No intervention | Group 1- infants with 25(OH)D above 15ng/ml (normal levels) will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height at the age of 3 years
Measured: 3 years after the recruitment begins
Secondary outcomes (1)
Bone densitometry by ultrasound
Measured: 3 years after recruitment begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avigdor Hevroni, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419821
- Sponsor's protocol ID
- protocol 5.3
- Acronym
- VitD
- Status last verified
- Aug 2011
- First submitted
- 17 Aug 2011
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Greer FR. Issues in establishing vitamin D recommendations for infants and children. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1759S-62S. doi: 10.1093/ajcn/80.6.1759S.
PubMed 15585801
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01419821
- Acronym / sponsor ID
- VitD / protocol 5.3
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Bone densitometry, Vitamin D supplementation, Growth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vit D supplementation | Active comparator | Drug: Vitamin DGroup 2-Infants with 25(OH)D below 15ng/ml receiving continued vitamin D supplementation of 800IU (4gtt/d) for one year. |
| Placebo group | Placebo comparator | Other: Placebo (for Vitamin D)Group 3- Infants with 25(OH)D below 15ng/ml those receiving the placebo. |
| Normal group | No intervention | –Group 1- infants with 25(OH)D above 15ng/ml (normal levels) will receive no intervention. |
Who may qualify
- Ages
- 9 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Parents that refuse to participate in this study, infants with any diagnosed chronic disease, and preterm infants less than 34 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: TipTipot Vitamin D 200IU/gtt800IU (4gtt/d) once a day for 2 years once a day. | Drug | Vit D supplementation |
| Placebo (for Vitamin D)4gtt/d for the placebo for two years. | Other | Placebo group |
Primary outcome
Height at the age of 3 years
Time frame: 3 years after the recruitment begins
1 secondary outcome
Bone densitometry by ultrasound
Time frame: 3 years after recruitment begins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
- Background: PubMed 15585801Greer FR. Issues in establishing vitamin D recommendations for infants and children. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1759S-62S. doi: 10.1093/ajcn/80.6.1759S.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avigdor Hevroni, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Deficiency, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avigdor Hevroni, MD (972508573982, Avigdor@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height at the age of 3 years (time frame: 3 years after the recruitment begins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01419821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013; AzTrials last refreshed its copy on 6 Nov 2026.