Vitamin D DeficiencyPhase 4NCT02186028
Effect of Oral Daily Supplementation With 400 IU Vs 200 IU of Vitamin D in Term Healthy Neonates
A Phase 4 study testing Vitamin D in people with Vitamin D Deficiency, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
The purpose of the study is to evaluate the effect of daily oral supplementation with vitamin D on serum Vitamin D levels in term healthy newborns. It has been found in various studies that vitamin D is highly deficient in Indian mother infant diads. Read more about this study
- Who is it for?
- Ages 2 to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2014to Jul 2015
- Phase
- Phase 4
- 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 2 to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestation > 37 weeks
- Birth weight >2.5 kg
- Informed consent of one of the parents
- Place of residence<10km
Who cannot join
- Presence of gross congenital malformation
- Need of resuscitation at birth
- Need for admission to neonatal ICU
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
India1 site
Kalawati Saran children's Hospital, Lady Hardinge Medical College
New Delhi, New Delhi, 110001
About this study
Official title: Effect Of Oral Daily Supplementation With 400 IU Vs 200 IU Of Vitamin D In Term Healthy Newborns: A Randomised Control Trial
The purpose of the study is to evaluate the effect of daily oral supplementation with vitamin D on serum Vitamin D levels in term healthy newborns. It has been found in various studies that vitamin D is highly deficient in Indian mother infant diads. There is a need to supplement vitamin D from neonatal period to prevent various metabolic disturbances due to vitamin D deficiency in later life. This study aims to find the effectiveness and the optimum dose of routine vitamin D supplementation in healthy term newborns for fulfilling the normal requirements in Indian infants.
Read the detailed description
Vitamin D deficiency is highly prevalent in India as reported in various studies. Vitamin D supplementation is necessary as vitamin D is required not only for prevention of rickets as traditionally thought, but also for its emerging role in development of diseases such as myopathic disorders, proneness to infection, autoimmune disorders and cancers .However supplementation studies are limited and predominantly from foreign countries. Moreover most of them report variable outcomes with no unanimous outcome with respect to optimum dose and duration of supplementation of vitamin D. Various national authorities recommend different doses of vitamin D for supplementation. American Academy of Pediatrics, The Institute of Medicine of National Academics, The Drug and Therapeutics Committee of the Lawson Wilkins Pediatric Endocrine Society, the Canadian Pediatric Society and European Society for Pediatric Endocrinology recommend that 400IU of vitamin D should be supplemented in all infants starting from within a few days of birth throughout childhood. ESPGHAN recommends 800-1000 IU for high risk infants, Ireland recommends 200IU vitamin D per day, UK does not recommend any supplements upto 6 months of age , however if formula milk intake <500ml/day then 300 IU is recommended. There are no such guidelines for India. Hence this study aims at evaluating the proportion of vitamin D deficient
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D
- Keywords
- oral daily supplementation with vitamin D for 6 months
- 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
Vit D 400 IU vs. Vit D 200 IU
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D 400 IU | Experimental | Vitamin D-400IU/ml- 1ml daily
Neonates will be administered Vitamin D 400 IU orally daily by the mother or other caregiver for a period of six months. The neonates will be followed up for compliance at 2 weeks, 6, 10 and 14 weeks and thereafter at 6 months of age. Receives: Drug: Vitamin D |
| Vitamin D 200IU | Active comparator | Vitamin D 400IU/ml : 0.5ml daily
Neonates will be administered Vitamin D 200 IU orally daily by the mother or other caregiver for a period of six months. The neonates will be followed up for compliance at 2 weeks, 6, 10 and 14 weeks and thereafter at 6 months of age. Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in vitamin D levels attained after oral supplementation with 400IU/day Vs 200IU/day of vitamin D for 6 months
Measured: 6 months
Secondary outcomes (1)
Proportion of vitamin D deficient term healthy neonates at birth
serum vitaminD levels > 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient <15 ng/ml - deficient
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sushma Nangia, M.D., Lady Hardinge Medical College
- Investigators
- Sushma Nangia, MD, DM, Study chair, Lady Hardinge Medical College & Kalawati Saran Children's HospitalArvind Saili, MD, Study director, Lady Hardinge Medical College & Kalawati Saran Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186028
- Sponsor's protocol ID
- LHMC/094/2012/VitD
- Status last verified
- Sep 2015
- First submitted
- 7 Jul 2014
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Oral Daily Supplementation With 400 IU Vs 200 IU Of Vitamin D In Term Healthy Newborns: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT02186028
- Acronym / sponsor ID
- LHMC/094/2012/VitD
- Conditions
- Vitamin D Deficiency
- Keywords
- oral daily supplementation with vitamin D for 6 months
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jul 2014 (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 the study is to evaluate the effect of daily oral supplementation with vitamin D on serum Vitamin D levels in term healthy newborns. It has been found in various studies that vitamin D is highly deficient in Indian mother infant diads. There is a need to supplement vitamin D from neonatal period to prevent various metabolic disturbances due to vitamin D deficiency in later life. This study aims to find the effectiveness and the optimum dose of routine vitamin D supplementation in healthy term newborns for fulfilling the normal requirements in Indian infants.
Detailed description
Vitamin D deficiency is highly prevalent in India as reported in various studies. Vitamin D supplementation is necessary as vitamin D is required not only for prevention of rickets as traditionally thought, but also for its emerging role in development of diseases such as myopathic disorders, proneness to infection, autoimmune disorders and cancers .However supplementation studies are limited and predominantly from foreign countries. Moreover most of them report variable outcomes with no unanimous outcome with respect to optimum dose and duration of supplementation of vitamin D. Various national authorities recommend different doses of vitamin D for supplementation. American Academy of Pediatrics, The Institute of Medicine of National Academics, The Drug and Therapeutics Committee of the Lawson Wilkins Pediatric Endocrine Society, the Canadian Pediatric Society and European Society for Pediatric Endocrinology recommend that 400IU of vitamin D should be supplemented in all infants starting from within a few days of birth throughout childhood. ESPGHAN recommends 800-1000 IU for high risk infants, Ireland recommends 200IU vitamin D per day, UK does not recommend any supplements upto 6 months of age , however if formula milk intake <500ml/day then 300 IU is recommended. There are no such guidelines for India. Hence this study aims at evaluating the proportion of vitamin D deficient
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D 400 IU | Experimental | Drug: Vitamin DVitamin D-400IU/ml- 1ml daily Neonates will be administered Vitamin D 400 IU orally daily by the mother or other caregiver for a period of six months. The neonates will be followed up for compliance at 2 weeks, 6, 10 and 14 weeks and thereafter at 6 months of age. |
| Vitamin D 200IU | Active comparator | Drug: Vitamin DVitamin D 400IU/ml : 0.5ml daily Neonates will be administered Vitamin D 200 IU orally daily by the mother or other caregiver for a period of six months. The neonates will be followed up for compliance at 2 weeks, 6, 10 and 14 weeks and thereafter at 6 months of age. |
Who may qualify
- Ages
- 2 to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestation > 37 weeks
- Birth weight >2.5 kg
- Informed consent of one of the parents
- Place of residence<10km
Key exclusion criteria (4 listed)
- Presence of gross congenital malformation
- Need of resuscitation at birth
- Need for admission to neonatal ICU
- Refusal of consent
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 DVit D 400 IU vs. Vit D 200 IU | Drug | Vitamin D 200IU, Vitamin D 400 IU |
Primary outcome
Difference in vitamin D levels attained after oral supplementation with 400IU/day Vs 200IU/day of vitamin D for 6 months
Time frame: 6 months
1 secondary outcome
Proportion of vitamin D deficient term healthy neonates at birth
Time frame: at birth
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 29 Sep 2015.
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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.
Sushma Nangia, MD, DM study chair
Lady Hardinge Medical College & Kalawati Saran Children's Hospital
Arvind Saili, MD study director
Lady Hardinge Medical College & Kalawati Saran Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Vitamin D Deficiency, run by Lady Hardinge Medical College 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 4 inclusion and 4 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 29 Sep 2015. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference in vitamin D levels attained after oral supplementation with 400IU/day Vs 200IU/day of vitamin D for 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2015.