Vitamin D DeficiencyDIVIDSNCT00415402
Effect of Vitamin D Supplementation on Health of Low Birth Weight Infants
A study testing Vitamin D3 in people with Vitamin D Deficiency, run by Delhi University at 1 site in India.
Trial summary
The purpose of this study is to determine whether a weekly supplement of vitamin D to low birth weight term infants will reduce their mortality and hospital admissions and improve their immunity. Read more about this study
- Who is it for?
- Ages 24 hours to 2 daysHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2007to Jul 2010
- 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 24 hours to 2 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born at term, as determined from last menstrual period
- Weighing < 2.5 kg
- Resident within 12 km of the hospital and expected to continue living in the area for the following 6 months
- With no severe congenital abnormalities
- No morbidity severe enough to be expected to result in death before 7 days due to severe respiratory distress, shock, pulmonary sepsis, etc.
- Parental informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial to Evaluate the Preventive Effect on Mortality and Serious Morbidity/ Hospitalisations of Daily Vitamin D Supplements in Small for Gestational Age Term Infants
The purpose of this study is to determine whether a weekly supplement of vitamin D to low birth weight term infants will reduce their mortality and hospital admissions and improve their immunity.
Read the detailed description
We are conducting a randomised controlled trial of weekly oral vitamin D supplements to low birth weight (< 2.5 kg) term infants born in a large government hospital catering to a low-middle income population in Delhi. Mothers and infants are recruited at delivery and given weekly vitamin D supplements or placebo until 6 months of age. Data on infant morbidity, sun exposure and diet, with particular emphasis on breast milk and other milk intake, is collected by fieldworkers visiting the homes each fortnight. Mothers are encouraged to bring their infants to the hospital in case of any illness and at these visits the infant is seen by the project doctor who treats the infant and records additional morbidity data. At 6 months blood samples are being collected from a 20% random subsample of infants for measurement of 25OHD and indicators of immune activation. The primary outcome is mortality or incidence of any illness requiring admission to hospital.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D3
- Keywords
- Vitamin D3, morbidity, mortality, low birth weight, supplementation, TH1, TH2, CRP, Neopterin, immune response
- 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 D3Drug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | non vitamin D containing sugar granules |
| Vitamin D3 | Experimental | vitamin D granules Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: weekly
Incidence of disease requiring hospitalization
Morbidity and hospitalization
Measured: weekly
Secondary outcomes (2)
Incidence of infectious disease not requiring hospitalization
Severe morbidity requiring hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startMar 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delhi University
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Sitaram Bhartia Institute of Science and Research
- Responsible party
- Principal investigator, Dr Geeta Trilok-Kumar, Delhi University
- Investigators
- Geeta Trilok-Kumar, PhD, Principal investigator, Institute of Home Economics, Delhi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415402
- Sponsor's protocol ID
- BT/PR 7489/PID/20/285/2006
- Other IDs
- IHE/VITD/2006
- Acronym
- DIVIDS
- Status last verified
- Aug 2012
- First submitted
- 21 Dec 2006
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kumar GT, Sachdev HS, Chellani H, Rehman AM, Singh V, Arora H, Filteau S. Effect of weekly vitamin D supplements on mortality, morbidity, and growth of low birthweight term infants in India up to age 6 months: randomised controlled trial. BMJ. 2011 May 31;342:d2975. doi: 10.1136/bmj.d2975.
PubMed 21628364Trilok-Kumar G, Arora H, Rajput M, Chellani H, Singh V, Raynes J, Arya S, Aggarwal S, Srivastava N, Sachdev HP, Filteau S. Effect of vitamin D supplementation of low birth weight term Indian infants from birth on cytokine production at 6 months. Eur J Clin Nutr. 2012 Jun;66(6):746-50. doi: 10.1038/ejcn.2012.33. Epub 2012 Apr 18.
PubMed 22510791Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
PubMed 33305842
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Evaluate the Preventive Effect on Mortality and Serious Morbidity/ Hospitalisations of Daily Vitamin D Supplements in Small for Gestational Age Term Infants
- ClinicalTrials.gov ID
- NCT00415402
- Acronym / sponsor ID
- DIVIDS / BT/PR 7489/PID/20/285/2006
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D3, morbidity, mortality, low birth weight, supplementation, TH1, TH2, CRP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Delhi UniversityUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Sitaram Bhartia Institute of Science and Research
- Study start
- Mar 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Dec 2006 (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.
The purpose of this study is to determine whether a weekly supplement of vitamin D to low birth weight term infants will reduce their mortality and hospital admissions and improve their immunity.
Detailed description
We are conducting a randomised controlled trial of weekly oral vitamin D supplements to low birth weight (< 2.5 kg) term infants born in a large government hospital catering to a low-middle income population in Delhi. Mothers and infants are recruited at delivery and given weekly vitamin D supplements or placebo until 6 months of age. Data on infant morbidity, sun exposure and diet, with particular emphasis on breast milk and other milk intake, is collected by fieldworkers visiting the homes each fortnight. Mothers are encouraged to bring their infants to the hospital in case of any illness and at these visits the infant is seen by the project doctor who treats the infant and records additional morbidity data. At 6 months blood samples are being collected from a 20% random subsample of infants for measurement of 25OHD and indicators of immune activation. The primary outcome is mortality or incidence of any illness requiring admission to hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | –non vitamin D containing sugar granules |
| Vitamin D3 | Experimental | Drug: Vitamin D3vitamin D granules |
Who may qualify
- Ages
- 24 hours to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Born at term, as determined from last menstrual period
- Weighing < 2.5 kg
- Resident within 12 km of the hospital and expected to continue living in the area for the following 6 months
- With no severe congenital abnormalities
- No morbidity severe enough to be expected to result in death before 7 days due to severe respiratory distress, shock, pulmonary sepsis, etc.
Key exclusion criteria (0 listed)
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 D3 | Drug | Vitamin D3 |
Primary outcome
Mortality
Time frame: weekly
Incidence of disease requiring hospitalization
Morbidity and hospitalization
Time frame: weekly
2 secondary outcomes
Incidence of infectious disease not requiring hospitalization
Severe morbidity requiring hospitalization
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 22 Aug 2012.
- Results publication: PubMed 21628364Kumar GT, Sachdev HS, Chellani H, Rehman AM, Singh V, Arora H, Filteau S. Effect of weekly vitamin D supplements on mortality, morbidity, and growth of low birthweight term infants in India up to age 6 months: randomised controlled trial. BMJ. 2011 May 31;342:d2975. doi: 10.1136/bmj.d2975.
- Results publication: PubMed 22510791Trilok-Kumar G, Arora H, Rajput M, Chellani H, Singh V, Raynes J, Arya S, Aggarwal S, Srivastava N, Sachdev HP, Filteau S. Effect of vitamin D supplementation of low birth weight term Indian infants from birth on cytokine production at 6 months. Eur J Clin Nutr. 2012 Jun;66(6):746-50. doi: 10.1038/ejcn.2012.33. Epub 2012 Apr 18.
- Derived from this study: PubMed 33305842Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
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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.
Geeta Trilok-Kumar, PhD principal investigator
Institute of Home Economics, Delhi University
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 D3 in people with Vitamin D Deficiency, run by Delhi University at 1 site in India.
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 6 inclusion and 0 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 22 Aug 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 India. 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?
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?
Mortality (time frame: weekly). The study lists 3 primary outcomes in all. 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 NCT00415402, which also lists 3 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 22 Aug 2012.