Vitamin D DeficiencyNCT00494104
Prevention of Vitamin D Deficiency
A study testing Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day in people with Vitamin D Deficiency, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D deficiency during winter. This trial is designed to determine how much supplemental vitamin D breastfed infants need to receive in order to remain free of vitamin D deficiency Read more about this study
- Who is it for?
- Ages 3 to 5 weeksHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2011
- 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 3 to 5 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term infant
- No major congenital malformations
- Less than one month old
- Breastfed, no other foods
Who cannot join
- Formula feeding
- Premature birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Vitamin D Deficiency in Breastfed Infants
Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D deficiency during winter. This trial is designed to determine how much supplemental vitamin D breastfed infants need to receive in order to remain free of vitamin D deficiency
Read the detailed description
It is increasingly being recognized that infants and children living at northern latitudes are at risk of vitamin D deficiency, especially if their skin is darkly pigmented. The study by the PI (Pediatrics 2006;118:603) was the first to demonstrate that infants with light skin pigmentation living at 41 degrees north are at risk of vitamin D deficiency. During winter (December - April) a full 78% of infants were vitamin D deficient if they did not receive vitamin D from an external source. Very few breastfed babies are currently receiving supplemental vitamin D. The recommended dose is 200 IU/day. However, there are questions about the adequacy of this dose of vitamin D for the prevention of vitamin D deficiency. The present trial is designed to determine whether a dose of 200 IU/day is effective or whether doses of 400 IU/day, 600 IU/day or 800 IU/day are required to prevent vitamin D deficiency reliably.
The trial is a randomized, prospective double-blind trial in which breastfed infants will receive 200 IU/day or 400 IU/day or 600 IU/day or 800 IU/day from 1 to 9 months of age. There will not be a placebo control group. Infants will be followed through 12 months of age. Normal term infants (birth weight >2500 g) who are born in June through November will be enrolled and randomized at 1 month of age. They will visit the study center at monthly intervals and will have capillary blood drawn at select ages. At 2 months and again in March or April whole body mineral content will be determined by DEXA. Infants will not be permitted to receive formula until 9 months of age. They may receive complementary foods beginning at 4 months of age. Vitamin D supplements will be weighed before dispensing and again when the empty and half-empty containers are returned. Study endpoints will be blood parameters and bone mineral content determined at the end of winter, i.e., between March and May 15. Blood parameters include 25-OHD, parathyroid hormone, calcium, alkaline phosphatase, osteocalcin, N-telopeptide, ferritin and transferrin receptor. 180 infants will be enrolled at 1 month of age in the expectation that 48 per group will complete the trial to at least 9 months of age.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
- Keywords
- vitamin D deficiency, breastfed infant, northern latitude, infant, breastfed, winter, vitamin D status
- Medical subject headings
- Vitamin D Deficiency, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/dayDietary supplement
Infants receive daily 0.5 ml of code labeled supplement
| Study group | Role | What they receive |
|---|---|---|
| 200 IU/day Vitamin D | Active comparator | 200 IU/day Vitamin D Receives: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day |
| 400 IU/day Vitamin D | Experimental | 400 IU/day Vitamin D Receives: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day |
| 600 IU/day Vitamin D | Experimental | 600 IU/day Vitamin D Receives: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day |
| 800 IU/day Vitamin D | Experimental | 800 IU/day Vitamin D Receives: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase
Measured: end of winter
Secondary outcomes (1)
whole body mineral content by DEXA
Measured: end of winter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startSep 2006
- Primary completionSep 2011
- Study completionSep 2011
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ekhard Ziegler, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494104
- Sponsor's protocol ID
- R01HD048870
- Other IDs
- R01HD048870
- Status last verified
- Sep 2006
- First submitted
- 28 Jun 2007
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ziegler EE, Nelson SE, Jeter JM. Vitamin D supplementation of breastfed infants: a randomized dose-response trial. Pediatr Res. 2014 Aug;76(2):177-83. doi: 10.1038/pr.2014.76. Epub 2014 May 23.
PubMed 24858141
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Vitamin D Deficiency in Breastfed Infants
- ClinicalTrials.gov ID
- NCT00494104
- Acronym / sponsor ID
- R01HD048870
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D deficiency, breastfed infant, northern latitude, infant, breastfed, winter, vitamin D status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Sep 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Jun 2007 (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.
Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D deficiency during winter. This trial is designed to determine how much supplemental vitamin D breastfed infants need to receive in order to remain free of vitamin D deficiency
Detailed description
It is increasingly being recognized that infants and children living at northern latitudes are at risk of vitamin D deficiency, especially if their skin is darkly pigmented. The study by the PI (Pediatrics 2006;118:603) was the first to demonstrate that infants with light skin pigmentation living at 41 degrees north are at risk of vitamin D deficiency. During winter (December - April) a full 78% of infants were vitamin D deficient if they did not receive vitamin D from an external source. Very few breastfed babies are currently receiving supplemental vitamin D. The recommended dose is 200 IU/day. However, there are questions about the adequacy of this dose of vitamin D for the prevention of vitamin D deficiency. The present trial is designed to determine whether a dose of 200 IU/day is effective or whether doses of 400 IU/day, 600 IU/day or 800 IU/day are required to prevent vitamin D deficiency reliably.
The trial is a randomized, prospective double-blind trial in which breastfed infants will receive 200 IU/day or 400 IU/day or 600 IU/day or 800 IU/day from 1 to 9 months of age. There will not be a placebo control group. Infants will be followed through 12 months of age. Normal term infants (birth weight >2500 g) who are born in June through November will be enrolled and randomized at 1 month of age. They will visit the study center at monthly intervals and will have capillary blood drawn at select ages. At 2 months and again in March or April whole body mineral content will be determined by DEXA. Infants will not be permitted to receive formula until 9 months of age. They may receive complementary foods beginning at 4 months of age. Vitamin D supplements will be weighed before dispensing and again when the empty and half-empty containers are returned. Study endpoints will be blood parameters and bone mineral content determined at the end of winter, i.e., between March and May 15. Blood parameters include 25-OHD, parathyroid hormone, calcium, alkaline phosphatase, osteocalcin, N-telopeptide, ferritin and transferrin receptor. 180 infants will be enrolled at 1 month of age in the expectation that 48 per group will complete the trial to at least 9 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 200 IU/day Vitamin D | Active comparator | Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day200 IU/day Vitamin D |
| 400 IU/day Vitamin D | Experimental | Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day400 IU/day Vitamin D |
| 600 IU/day Vitamin D | Experimental | Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day600 IU/day Vitamin D |
| 800 IU/day Vitamin D | Experimental | Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day800 IU/day Vitamin D |
Who may qualify
- Ages
- 3 to 5 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Term infant
- No major congenital malformations
- Less than one month old
- Breastfed, no other foods
Key exclusion criteria (2 listed)
- Formula feeding
- Premature birth
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 D drops, 200 or 400 or 600 IU/day or 800 IU/dayInfants receive daily 0.5 ml of code labeled supplement | Dietary supplement | 200 IU/day Vitamin D, 400 IU/day Vitamin D, 600 IU/day Vitamin D, 800 IU/day Vitamin D |
Primary outcome
Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase
Time frame: end of winter
1 secondary outcome
whole body mineral content by DEXA
Time frame: end of winter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
- Derived from this study: PubMed 24858141Ziegler EE, Nelson SE, Jeter JM. Vitamin D supplementation of breastfed infants: a randomized dose-response trial. Pediatr Res. 2014 Aug;76(2):177-83. doi: 10.1038/pr.2014.76. Epub 2014 May 23.
Related trials for Vitamin D Deficiency
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
Not yet recruiting
The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
Hypovitaminosis D
RecruitingPhase 3
OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity
Vision Loss Night, Vision Disorders
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.
Ekhard Ziegler, MD principal investigator
University of Iowa
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 drops, 200 or 400 or 600 IU/day or 800 IU/day in people with Vitamin D Deficiency, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 18 Dec 2012. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase (time frame: end of winter). 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 NCT00494104, 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 18 Dec 2012; AzTrials last refreshed its copy on 6 Nov 2026.