Vitamin D DeficiencyNCT00697294
Impact of Vitamin D Status on Bones in Breastfed Infants
A study testing Tri-Vi-Sol in people with Vitamin D Deficiency, run by Baylor College of Medicine at 3 sites in United States.
Trial summary
Vitamin D deficiency is widespread and linked to decreased bone mineral content. Little data exists regarding the vitamin D status and the relationship of 25-hydroxyvitamin D (25-OHD) status to functional bone health outcomes in Hispanic infants. Read more about this study
- Who is it for?
- Ages Up to 2 hoursHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Tri-Vi-Sol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2008to Nov 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 Up to 2 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term infants (37-42 weeks)
- Appropriate for gestational age
- Free of major congenital anomalies
- Born to mothers without a history of diabetes or chronic illness who intend to exclusively breastfeed
Who cannot join
- Any child who does not meet the above inclusion criteria
- Insufficient cord blood available to determine cord 25-hydroxyvitamin D status
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baylor College of Medicine
Houston, Texas, 77030
Ben Taub General Hospital
Houston, Texas, 77030
St Lukes Episcopal Hospital
Houston, Texas, 77030
About this study
Official title: Vitamin D Status and Impact on Bone Mineralization in Human Milk Fed Hispanic and Caucasian Infants
Vitamin D deficiency is widespread and linked to decreased bone mineral content. Little data exists regarding the vitamin D status and the relationship of 25-hydroxyvitamin D (25-OHD) status to functional bone health outcomes in Hispanic infants. To evaluate this, we plan an observational cohort of full term, healthy, exclusively breastfed Hispanic and Caucasian infants. We hypothesize serum 25-OHD measured in cord blood will be significantly lower in Hispanic than Caucasian infants, with 25-OHD less than 20 ng/mL found in at least 50% of Hispanic neonates. Secondary aims evaluate the relationship between 25-OHD levels and bone mineral status at baseline and after 3 months of 400 IU/day supplemental vitamin D3. Whole body bone density scan (DXA) and bone ultrasound (SOS U/S) will be measured shortly after birth, then again after supplementation. Data from this study will provide information needed to design further randomized trials and interventions.
Read the detailed description
In recent years, severe vitamin D deficiency has resurfaced as a major public health concern. Nutritional rickets is widespread, and a recent report on this disease in Texas showed Hispanic children are at increased risk. Long-term follow-up has demonstrated that vitamin D deficient infants are more likely to have decreased bone mineral status in late childhood. Additionally, vitamin D deficiency has been linked to changes in fetal "imprinting" and increased susceptibility to autoimmune diseases, immune deficiency, and malignancy. At birth, an infant's vitamin D status is entirely dependent on the vitamin D status of the mother. Many studies have shown vitamin D deficiency is very common in mother-child pairs, especially in dark-skinned individuals. However, few data exist regarding the vitamin D status in Hispanic infants. Low milk intakes and decreased sun exposure with urbanization makes this a very high-risk group among infants in Texas.
Potential subjects will be identified by study personnel in labor and delivery at St. Luke's and Ben Taub Hospitals and in the normal newborn nurseries. The parent/guardian will be approached and the study will be explained in full. A time for questions will be allowed. Once the parent/guardian agrees to his/her child's participation, an informed written consent form will be signed. Subject confidentiality will be maintained within limits of the law. All names and personal information will be accessed only by the investigators and authorized personnel. There will be no possibility of coercion as subjects will not have any relationship of dependency with the investigators.
A cohort of Hispanic and Caucasian infants will be recruited and followed. Other ethnic groups will not be excluded, but will not be analyzed in terms of the primary outcome. Race and ethnicity will be classified according to mother's self classification. The interventions will not differ between the groups.
This study includes 3 study visits:
- Baseline inpatient visit at birth - while hospitalized to obtain consent, obtain cord blood sample, and mother to complete a questionnaire
- 1 week after initial hospital discharge - first outpatient visit to obtain other baseline data (see below) and to start the vitamin D drops
- At 3 mo of life - second outpatient visit to obtain final data (see below) and discontinue vitamin D drops
Visit 1 (Inpatient): After consent has been obtained and upon birth, cord blood will be obtained and analyzed using the Diasorin RIA for 25-OHD. In addition, serum ionized calcium and intact parathyroid hormone (PTH) concentration will be measured on cord blood. Mothers will be given a brief questionnaire to determine their risk of vitamin D deficiency (do they take vitamins, supplements, sun exposure). Follow-up outpatient appointments will be scheduled.
Visit 2 (First Outpatient Visit): Infants will have a speed of sound ultrasound (SOS U/S) and whole body dual-energy x-ray absorptiometry (DXA) performed at 1 week after hospital discharge. Supplements of 400 IU of vitamin D per day will be provided for all infants free of charge starting at the time of the body composition analysis (Vitamin D supplementation is recommended by the American Academy of Pediatrics for all infants who are exclusively breastfeeding).
Visit 3 (Second Outpatient Visit): Infants will return at three months of age and repeat measurements of serum 25-OHD, PTH, bone SOS U/S, and whole body DXA will be performed. At this time a second brief questionnaire will be given to the mother to assess the risks of vitamin D deficiency in the child. Vitamin D drops will be discontinued.
Between visits, investigators will call the family to check on breast feeding status.
At delivery, cord blood will be obtained and analyzed for 25-OHD, serum ionized calcium, and intact parathyroid hormone (PTH) concentration. At three months of age blood will be drawn for 25-OHD and PTH. The purpose of the blood draw is to assess the vitamin D status in the newborn infant. This is the primary aim of the study.
- 5 cc (one teaspoon) of cord blood will be obtained at visit 1, and 5 cc (one teaspoon) blood will be drawn from patient at the third visit (three months of age).
- Total = 2 teaspoons
There will be no study costs passed on the subject's family. Study investigations (laboratory, bone mineral assessment) will be paid for by the researchers. Costs for routine medical care, not associated with the study, but associated with delivery and hospitalization of the newly born child will be the responsibility of the family and their insurance company.
A total of 60 subjects will be enrolled in the protocol. Enrollment of 30 Hispanic infants and 30 Caucasian infants will provide a power > 80% to demonstrate a significantly lower cord 25-OHD concentration in Hispanic infants at p<0.05, the primary outcome.
- Conditions
- Vitamin D Deficiency
- Being tested
- Tri-Vi-Sol
- Keywords
- Vitamin D deficiency, Infants, Breast feeding
- 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.
Tri-Vi-SolDietary supplement
Also called ADC drops
All subjects will begin vitamin D supplementation at the first outpatient visit (at 1 week of life) and will continue through the second outpatient visit (at 3 months of age). Dosage will be 400 IU/day of vitamin D in the form of Tri-Vi-Sol vitamin drops.
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Experimental | Subjects will serve as their own control in this single-arm protocol. All subjects will receive 400 IU/day of vitamin D as the intervention. Comparisons will be made between Caucasian and Hispanic infants. Receives: Dietary Supplement: Tri-Vi-Sol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the relative frequency of vitamin D deficiency in human milk fed Hispanic compared to Caucasian newborn infants in Houston, Texas.
Measured: End of study
Secondary outcomes (2)
To determine if infant vitamin D status is related to bone mineral status at birth
Measured: End of study
To determine the effects of vitamin D supplementation on 25-hydroxyvitamin D (25-OHD) concentration and bone mineral status vitamin D deficient and vitamin D replete infants at 3 months of age.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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 Baylor College of MedicineThe 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 N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Abrams, MD, Baylor College of Medicine
- Investigators
- Steven A Abrams, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697294
- Sponsor's protocol ID
- H-22293
- Status last verified
- Dec 2011
- First submitted
- 3 Jun 2008
- Last updated
- 5 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Shah M, Salhab N, Patterson D, Seikaly MG. Nutritional rickets still afflict children in north Texas. Tex Med. 2000 Jun;96(6):64-8.
PubMed 10876374Javaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 Jan 7;367(9504):36-43. doi: 10.1016/S0140-6736(06)67922-1.
PubMed 16399151McGrath J. Does 'imprinting' with low prenatal vitamin D contribute to the risk of various adult disorders? Med Hypotheses. 2001 Mar;56(3):367-71. doi: 10.1054/mehy.2000.1226.
PubMed 11359362Basile LA, Taylor SN, Wagner CL, Quinones L, Hollis BW. Neonatal vitamin D status at birth at latitude 32 degrees 72': evidence of deficiency. J Perinatol. 2007 Sep;27(9):568-71. doi: 10.1038/sj.jp.7211796. Epub 2007 Jul 12.
PubMed 17625571Dijkstra SH, van Beek A, Janssen JW, de Vleeschouwer LH, Huysman WA, van den Akker EL. High prevalence of vitamin D deficiency in newborn infants of high-risk mothers. Arch Dis Child. 2007 Sep;92(9):750-3. doi: 10.1136/adc.2006.105577.
PubMed 17715438Lee JM, Smith JR, Philipp BL, Chen TC, Mathieu J, Holick MF. Vitamin D deficiency in a healthy group of mothers and newborn infants. Clin Pediatr (Phila). 2007 Jan;46(1):42-4. doi: 10.1177/0009922806289311.
PubMed 17164508Brunvand L, Haga P, Tangsrud SE, Haug E. Congestive heart failure caused by vitamin D deficiency? Acta Paediatr. 1995 Jan;84(1):106-8. doi: 10.1111/j.1651-2227.1995.tb13499.x.
PubMed 7734890Brooke OG, Butters F, Wood C. Intrauterine vitamin D nutrition and postnatal growth in Asian infants. Br Med J (Clin Res Ed). 1981 Oct 17;283(6298):1024. doi: 10.1136/bmj.283.6298.1024. No abstract available.
PubMed 6794748Cockburn F, Belton NR, Purvis RJ, Giles MM, Brown JK, Turner TL, Wilkinson EM, Forfar JO, Barrie WJ, McKay GS, Pocock SJ. Maternal vitamin D intake and mineral metabolism in mothers and their newborn infants. Br Med J. 1980 Jul 5;281(6232):11-4. doi: 10.1136/bmj.281.6232.11.
PubMed 7407476Alfaham M, Woodhead S, Pask G, Davies D. Vitamin D deficiency: a concern in pregnant Asian women. Br J Nutr. 1995 Jun;73(6):881-7. doi: 10.1079/bjn19950093.
PubMed 7632669Datta S, Alfaham M, Davies DP, Dunstan F, Woodhead S, Evans J, Richards B. Vitamin D deficiency in pregnant women from a non-European ethnic minority population--an interventional study. BJOG. 2002 Aug;109(8):905-8. doi: 10.1111/j.1471-0528.2002.01171.x.
PubMed 12197370Waiters B, Godel JC, Basu TK. Perinatal vitamin D and calcium status of northern Canadian mothers and their newborn infants. J Am Coll Nutr. 1999 Apr;18(2):122-6. doi: 10.1080/07315724.1999.10718839.
PubMed 10204827Molla AM, Al Badawi M, Hammoud MS, Molla AM, Shukkur M, Thalib L, Eliwa MS. Vitamin D status of mothers and their neonates in Kuwait. Pediatr Int. 2005 Dec;47(6):649-52. doi: 10.1111/j.1442-200x.2005.02141.x.
PubMed 16354218Nicolaidou P, Hatzistamatiou Z, Papadopoulou A, Kaleyias J, Floropoulou E, Lagona E, Tsagris V, Costalos C, Antsaklis A. Low vitamin D status in mother-newborn pairs in Greece. Calcif Tissue Int. 2006 Jun;78(6):337-42. doi: 10.1007/s00223-006-0007-5. Epub 2006 Jul 7.
PubMed 16830197Abrams SA, Copeland KC, Gunn SK, Stuff JE, Clarke LL, Ellis KJ. Calcium absorption and kinetics are similar in 7- and 8-year-old Mexican-American and Caucasian girls despite hormonal differences. J Nutr. 1999 Mar;129(3):666-71. doi: 10.1093/jn/129.3.666.
PubMed 10082772
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status and Impact on Bone Mineralization in Human Milk Fed Hispanic and Caucasian Infants
- ClinicalTrials.gov ID
- NCT00697294
- Acronym / sponsor ID
- H-22293
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D deficiency, Infants, Breast feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 Jun 2008 (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.
Vitamin D deficiency is widespread and linked to decreased bone mineral content. Little data exists regarding the vitamin D status and the relationship of 25-hydroxyvitamin D (25-OHD) status to functional bone health outcomes in Hispanic infants. To evaluate this, we plan an observational cohort of full term, healthy, exclusively breastfed Hispanic and Caucasian infants. We hypothesize serum 25-OHD measured in cord blood will be significantly lower in Hispanic than Caucasian infants, with 25-OHD less than 20 ng/mL found in at least 50% of Hispanic neonates. Secondary aims evaluate the relationship between 25-OHD levels and bone mineral status at baseline and after 3 months of 400 IU/day supplemental vitamin D3. Whole body bone density scan (DXA) and bone ultrasound (SOS U/S) will be measured shortly after birth, then again after supplementation. Data from this study will provide information needed to design further randomized trials and interventions.
Detailed description
In recent years, severe vitamin D deficiency has resurfaced as a major public health concern. Nutritional rickets is widespread, and a recent report on this disease in Texas showed Hispanic children are at increased risk. Long-term follow-up has demonstrated that vitamin D deficient infants are more likely to have decreased bone mineral status in late childhood. Additionally, vitamin D deficiency has been linked to changes in fetal "imprinting" and increased susceptibility to autoimmune diseases, immune deficiency, and malignancy. At birth, an infant's vitamin D status is entirely dependent on the vitamin D status of the mother. Many studies have shown vitamin D deficiency is very common in mother-child pairs, especially in dark-skinned individuals. However, few data exist regarding the vitamin D status in Hispanic infants. Low milk intakes and decreased sun exposure with urbanization makes this a very high-risk group among infants in Texas.
Potential subjects will be identified by study personnel in labor and delivery at St. Luke's and Ben Taub Hospitals and in the normal newborn nurseries. The parent/guardian will be approached and the study will be explained in full. A time for questions will be allowed. Once the parent/guardian agrees to his/her child's participation, an informed written consent form will be signed. Subject confidentiality will be maintained within limits of the law. All names and personal information will be accessed only by the investigators and authorized personnel. There will be no possibility of coercion as subjects will not have any relationship of dependency with the investigators.
A cohort of Hispanic and Caucasian infants will be recruited and followed. Other ethnic groups will not be excluded, but will not be analyzed in terms of the primary outcome. Race and ethnicity will be classified according to mother's self classification. The interventions will not differ between the groups.
This study includes 3 study visits:
- Baseline inpatient visit at birth - while hospitalized to obtain consent, obtain cord blood sample, and mother to complete a questionnaire
- 1 week after initial hospital discharge - first outpatient visit to obtain other baseline data (see below) and to start the vitamin D drops
- At 3 mo of life - second outpatient visit to obtain final data (see below) and discontinue vitamin D drops
Visit 1 (Inpatient): After consent has been obtained and upon birth, cord blood will be obtained and analyzed using the Diasorin RIA for 25-OHD. In addition, serum ionized calcium and intact parathyroid hormone (PTH) concentration will be measured on cord blood. Mothers will be given a brief questionnaire to determine their risk of vitamin D deficiency (do they take vitamins, supplements, sun exposure). Follow-up outpatient appointments will be scheduled.
Visit 2 (First Outpatient Visit): Infants will have a speed of sound ultrasound (SOS U/S) and whole body dual-energy x-ray absorptiometry (DXA) performed at 1 week after hospital discharge. Supplements of 400 IU of vitamin D per day will be provided for all infants free of charge starting at the time of the body composition analysis (Vitamin D supplementation is recommended by the American Academy of Pediatrics for all infants who are exclusively breastfeeding).
Visit 3 (Second Outpatient Visit): Infants will return at three months of age and repeat measurements of serum 25-OHD, PTH, bone SOS U/S, and whole body DXA will be performed. At this time a second brief questionnaire will be given to the mother to assess the risks of vitamin D deficiency in the child. Vitamin D drops will be discontinued.
Between visits, investigators will call the family to check on breast feeding status.
At delivery, cord blood will be obtained and analyzed for 25-OHD, serum ionized calcium, and intact parathyroid hormone (PTH) concentration. At three months of age blood will be drawn for 25-OHD and PTH. The purpose of the blood draw is to assess the vitamin D status in the newborn infant. This is the primary aim of the study.
- 5 cc (one teaspoon) of cord blood will be obtained at visit 1, and 5 cc (one teaspoon) blood will be drawn from patient at the third visit (three months of age).
- Total = 2 teaspoons
There will be no study costs passed on the subject's family. Study investigations (laboratory, bone mineral assessment) will be paid for by the researchers. Costs for routine medical care, not associated with the study, but associated with delivery and hospitalization of the newly born child will be the responsibility of the family and their insurance company.
A total of 60 subjects will be enrolled in the protocol. Enrollment of 30 Hispanic infants and 30 Caucasian infants will provide a power > 80% to demonstrate a significantly lower cord 25-OHD concentration in Hispanic infants at p<0.05, the primary outcome.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supplement | Experimental | Dietary Supplement: Tri-Vi-SolSubjects will serve as their own control in this single-arm protocol. All subjects will receive 400 IU/day of vitamin D as the intervention. Comparisons will be made between Caucasian and Hispanic infants. |
Who may qualify
- Ages
- Up to 2 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Full term infants (37-42 weeks)
- Appropriate for gestational age
- Free of major congenital anomalies
- Born to mothers without a history of diabetes or chronic illness who intend to exclusively breastfeed
Key exclusion criteria (2 listed)
- Any child who does not meet the above inclusion criteria
- Insufficient cord blood available to determine cord 25-hydroxyvitamin D status
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 |
|---|---|---|
| Tri-Vi-SolAlso: ADC dropsAll subjects will begin vitamin D supplementation at the first outpatient visit (at 1 week of life) and will continue through the second outpatient visit (at 3 months of age). Dosage will be 400 IU/day of vitamin D in the form of Tri-Vi-Sol vitamin drops. | Dietary supplement | Supplement |
Primary outcome
To evaluate the relative frequency of vitamin D deficiency in human milk fed Hispanic compared to Caucasian newborn infants in Houston, Texas.
Time frame: End of study
2 secondary outcomes
To determine if infant vitamin D status is related to bone mineral status at birth
Time frame: End of study
To determine the effects of vitamin D supplementation on 25-hydroxyvitamin D (25-OHD) concentration and bone mineral status vitamin D deficient and vitamin D replete infants at 3 months of age.
Time frame: End of study
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 5 Dec 2011.
- Background: PubMed 10876374Shah M, Salhab N, Patterson D, Seikaly MG. Nutritional rickets still afflict children in north Texas. Tex Med. 2000 Jun;96(6):64-8.
- Background: PubMed 16399151Javaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 Jan 7;367(9504):36-43. doi: 10.1016/S0140-6736(06)67922-1.
- Background: PubMed 11359362McGrath J. Does 'imprinting' with low prenatal vitamin D contribute to the risk of various adult disorders? Med Hypotheses. 2001 Mar;56(3):367-71. doi: 10.1054/mehy.2000.1226.
- Background: PubMed 17625571Basile LA, Taylor SN, Wagner CL, Quinones L, Hollis BW. Neonatal vitamin D status at birth at latitude 32 degrees 72': evidence of deficiency. J Perinatol. 2007 Sep;27(9):568-71. doi: 10.1038/sj.jp.7211796. Epub 2007 Jul 12.
- Background: PubMed 17715438Dijkstra SH, van Beek A, Janssen JW, de Vleeschouwer LH, Huysman WA, van den Akker EL. High prevalence of vitamin D deficiency in newborn infants of high-risk mothers. Arch Dis Child. 2007 Sep;92(9):750-3. doi: 10.1136/adc.2006.105577.
- Background: PubMed 17164508Lee JM, Smith JR, Philipp BL, Chen TC, Mathieu J, Holick MF. Vitamin D deficiency in a healthy group of mothers and newborn infants. Clin Pediatr (Phila). 2007 Jan;46(1):42-4. doi: 10.1177/0009922806289311.
- Background: PubMed 7734890Brunvand L, Haga P, Tangsrud SE, Haug E. Congestive heart failure caused by vitamin D deficiency? Acta Paediatr. 1995 Jan;84(1):106-8. doi: 10.1111/j.1651-2227.1995.tb13499.x.
- Background: PubMed 6794748Brooke OG, Butters F, Wood C. Intrauterine vitamin D nutrition and postnatal growth in Asian infants. Br Med J (Clin Res Ed). 1981 Oct 17;283(6298):1024. doi: 10.1136/bmj.283.6298.1024. No abstract available.
- Background: PubMed 7407476Cockburn F, Belton NR, Purvis RJ, Giles MM, Brown JK, Turner TL, Wilkinson EM, Forfar JO, Barrie WJ, McKay GS, Pocock SJ. Maternal vitamin D intake and mineral metabolism in mothers and their newborn infants. Br Med J. 1980 Jul 5;281(6232):11-4. doi: 10.1136/bmj.281.6232.11.
- Background: PubMed 7632669Alfaham M, Woodhead S, Pask G, Davies D. Vitamin D deficiency: a concern in pregnant Asian women. Br J Nutr. 1995 Jun;73(6):881-7. doi: 10.1079/bjn19950093.
- Background: PubMed 12197370Datta S, Alfaham M, Davies DP, Dunstan F, Woodhead S, Evans J, Richards B. Vitamin D deficiency in pregnant women from a non-European ethnic minority population--an interventional study. BJOG. 2002 Aug;109(8):905-8. doi: 10.1111/j.1471-0528.2002.01171.x.
- Background: PubMed 10204827Waiters B, Godel JC, Basu TK. Perinatal vitamin D and calcium status of northern Canadian mothers and their newborn infants. J Am Coll Nutr. 1999 Apr;18(2):122-6. doi: 10.1080/07315724.1999.10718839.
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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.
Steven A Abrams, MD principal investigator
Baylor College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tri-Vi-Sol in people with Vitamin D Deficiency, run by Baylor College of Medicine at 3 sites 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 5 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
To evaluate the relative frequency of vitamin D deficiency in human milk fed Hispanic compared to Caucasian newborn infants in Houston, Texas. (time frame: End of study). 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 NCT00697294, which also lists 20 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 5 Dec 2011.