- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00697294
Impact of Vitamin D Status on Bones in Breastfed Infants
Vitamin D Status and Impact on Bone Mineralization in Human Milk Fed Hispanic and Caucasian Infants
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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Houston, Texas, 미국, 77030
- Ben Taub General Hospital
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Houston, Texas, 미국, 77030
- St Lukes Episcopal Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any child who does not meet the above inclusion criteria
- Insufficient cord blood available to determine cord 25-hydroxyvitamin D status
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Supplement
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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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To evaluate the relative frequency of vitamin D deficiency in human milk fed Hispanic compared to Caucasian newborn infants in Houston, Texas.
기간: End of study
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End of study
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2차 결과 측정
결과 측정 |
기간 |
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To determine if infant vitamin D status is related to bone mineral status at birth
기간: End of study
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End of study
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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.
기간: End of study
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End of study
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공동 작업자 및 조사자
수사관
- 수석 연구원: Steven A Abrams, MD, Baylor College of Medicine
간행물 및 유용한 링크
일반 간행물
- Zadshir A, Tareen N, Pan D, Norris K, Martins D. The prevalence of hypovitaminosis D among US adults: data from the NHANES III. Ethn Dis. 2005 Autumn;15(4 Suppl 5):S5-97-101.
- Javaid 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. Erratum In: Lancet. 2006 May 6;367(9521):1486.
- Looker AC, Orwoll ES, Johnston CC Jr, Lindsay RL, Wahner HW, Dunn WL, Calvo MS, Harris TB, Heyse SP. Prevalence of low femoral bone density in older U.S. adults from NHANES III. J Bone Miner Res. 1997 Nov;12(11):1761-8. doi: 10.1359/jbmr.1997.12.11.1761.
- Shah M, Salhab N, Patterson D, Seikaly MG. Nutritional rickets still afflict children in north Texas. Tex Med. 2000 Jun;96(6):64-8.
- McGrath 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.
- Basile 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.
- Dijkstra 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. Erratum In: Arch Dis Child. 2007 Nov;92(11):1049.
- Lee 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.
- Brunvand 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.
- Brooke 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.
- Cockburn 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.
- Alfaham 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.
- Datta 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.
- Waiters 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.
- Molla 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.
- Nicolaidou 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.
- Abrams 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.
- Reasner CA 2nd, Dunn JF, Fetchick DA, Liel Y, Hollis BW, Epstein S, Shary J, Mundy GR, Bell NH. Alteration of vitamin D metabolism in Mexican-Americans. J Bone Miner Res. 1990 Jan;5(1):13-7. doi: 10.1002/jbmr.5650050105.
- Ashraf A, Mick G, Atchison J, Petrey B, Abdullatif H, McCormick K. Prevalence of hypovitaminosis D in early infantile hypocalcemia. J Pediatr Endocrinol Metab. 2006 Aug;19(8):1025-31. doi: 10.1515/jpem.2006.19.8.1025.
- Abrams SA, Hawthorne KM, Rogers SP, Hicks PD, Carpenter TO. Effects of ethnicity and vitamin D supplementation on vitamin D status and changes in bone mineral content in infants. BMC Pediatr. 2012 Jan 16;12:6. doi: 10.1186/1471-2431-12-6.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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