Vitamin d DeficiencyPhase 2BSSNCT00886379
Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
A Phase 2 study testing Mongolian milk without vitamin D, Mongolian milk with vitamin D and UHT milk in people with Vitamin d Deficiency, run by Brigham and Women's Hospital.
Trial summary
This intervention study will address the impact of vitamin D fortified milk and vitamin D supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone, academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for eczema) of Mongolian children. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin d Deficiency
- What is being tested?
- Mongolian milk without vitamin D, Mongolian milk with vitamin D and UHT milk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in 3rd and 4th grade from selected Mongolian schools.
- School selection will consider:
- socioeconomic position;
- geographic location;
- school size;
- current lunch or supplementation program; and
- the interest and willingness to participate of the school's administration and faculty.
Who cannot join
- Allergy to milk or wheat products.
About this study
This intervention study will address the impact of vitamin D fortified milk and vitamin D supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone, academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for eczema) of Mongolian children.
- Conditions
- Vitamin d Deficiency
- Being tested
- Mongolian milk without vitamin D, Mongolian milk with vitamin D, UHT milk, Milk Substitute, Seasonal D supplement
- Keywords
- vitamin d, children, Mongolia
- 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.
Mongolian milk without vitamin DDietary supplement
Also called Guum milk
710ml per day for 49 days
Mongolian milk with vitamin DDietary supplement
Also called Guum milk
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
UHT milkDietary supplement
Also called Gossner milk
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
Milk SubstituteDietary supplement
Also called Mead Johnson
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
Seasonal D supplementDietary supplement
Also called Tish Con
Deliver dosage of 13,700 IU vitamin D over 7 days
Daily D supplementDietary supplement
Also called Tish Con
Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Mongolian milk without D Receives: Dietary Supplement: Mongolian milk without vitamin D |
| 2 | Experimental | Mongolian milk with vitamin D Receives: Dietary Supplement: Mongolian milk with vitamin D |
| 3 | Experimental | Ultra High Temperature (UHT) milk Receives: Dietary Supplement: UHT milk |
| 4 | Experimental | Milk Substitute Receives: Dietary Supplement: Milk Substitute |
| 5 | Experimental | Seasonal D Receives: Dietary Supplement: Seasonal D supplement |
| 6 | Experimental | Daily D Receives: Dietary Supplement: Daily D supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry
Measured: Blood was analyzed at day 0 and day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin d DeficiencyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Rich-Edwards, Brigham and Women's Hospital
- Investigators
- Janet Rich-Edwards, Sc.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886379
- Sponsor's protocol ID
- BSS-103306
- Acronym
- BSS
- Status last verified
- Feb 2021
- First submitted
- 20 Apr 2009
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rich-Edwards JW, Ganmaa D, Pollak MN, Nakamoto EK, Kleinman K, Tserendolgor U, Willett WC, Frazier AL. Milk consumption and the prepubertal somatotropic axis. Nutr J. 2007 Sep 27;6:28. doi: 10.1186/1475-2891-6-28.
PubMed 17900364Rich-Edwards JW, Ganmaa D, Kleinman K, Sumberzul N, Holick MF, Lkhagvasuren T, Dulguun B, Burke A, Frazier AL. Randomized trial of fortified milk and supplements to raise 25-hydroxyvitamin D concentrations in schoolchildren in Mongolia. Am J Clin Nutr. 2011 Aug;94(2):578-84. doi: 10.3945/ajcn.110.008771. Epub 2011 Jun 22.
PubMed 21697075
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
- ClinicalTrials.gov ID
- NCT00886379
- Acronym / sponsor ID
- BSS / BSS-103306
- Conditions
- Vitamin d Deficiency
- Keywords
- vitamin d, children, Mongolia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Posted 23 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This intervention study will address the impact of vitamin D fortified milk and vitamin D supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone, academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for eczema) of Mongolian children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Mongolian milk without vitamin DMongolian milk without D |
| 2 | Experimental | Dietary Supplement: Mongolian milk with vitamin DMongolian milk with vitamin D |
| 3 | Experimental | Dietary Supplement: UHT milkUltra High Temperature (UHT) milk |
| 4 | Experimental | Dietary Supplement: Milk SubstituteMilk Substitute |
| 5 | Experimental | Dietary Supplement: Seasonal D supplementSeasonal D |
| 6 | Experimental | Dietary Supplement: Daily D supplementDaily D |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children in 3rd and 4th grade from selected Mongolian schools.
- School selection will consider:
Key exclusion criteria (1 listed)
- Allergy to milk or wheat products.
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 |
|---|---|---|
| Mongolian milk without vitamin DAlso: Guum milk710ml per day for 49 days | Dietary supplement | 1 |
| Mongolian milk with vitamin DAlso: Guum milk710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. | Dietary supplement | 2 |
| UHT milkAlso: Gossner milk710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. | Dietary supplement | 3 |
| Milk SubstituteAlso: Mead Johnson710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. | Dietary supplement | 4 |
| Seasonal D supplementAlso: Tish ConDeliver dosage of 13,700 IU vitamin D over 7 days | Dietary supplement | 5 |
| Daily D supplementAlso: Tish ConDeliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days. | Dietary supplement | 6 |
Primary outcome
Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
Time frame: Blood was analyzed at day 0 and day 49
Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17900364Rich-Edwards JW, Ganmaa D, Pollak MN, Nakamoto EK, Kleinman K, Tserendolgor U, Willett WC, Frazier AL. Milk consumption and the prepubertal somatotropic axis. Nutr J. 2007 Sep 27;6:28. doi: 10.1186/1475-2891-6-28.
- Derived from this study: PubMed 21697075Rich-Edwards JW, Ganmaa D, Kleinman K, Sumberzul N, Holick MF, Lkhagvasuren T, Dulguun B, Burke A, Frazier AL. Randomized trial of fortified milk and supplements to raise 25-hydroxyvitamin D concentrations in schoolchildren in Mongolia. Am J Clin Nutr. 2011 Aug;94(2):578-84. doi: 10.3945/ajcn.110.008771. Epub 2011 Jun 22.
Related trials for Vitamin d Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
Janet Rich-Edwards, Sc.D. principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mongolian milk without vitamin D, Mongolian milk with vitamin D and UHT milk in people with Vitamin d Deficiency, run by Brigham and Women's Hospital.
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 7 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: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum 25-hydroxyvitamin D Concentrations in Schoolchildren (time frame: Blood was analyzed at day 0 and day 49). 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 NCT00886379, which also lists 2 linked publications.
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 23 Mar 2021.