Clinical trial NCT00610688: Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Official title: High Prevalence of Rickets and Subclinical Maternal and Childhood Vitamin D Deficiency in the Middle East: a Randomized Controlled Trial of Prenatal Vitamin D Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitamin D Deficiency
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: United Arab Emirates University
name: Thrasher Research Fund
First posted: 2008-02-08
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.

Detailed description: Three dosages of Vitamin D will be administered; 400IU, 2000IU and 4000IU per day to pregnant women starting at less than 16 week gestation continued until delivery. The dose will be provided using a randomized control method. Serum levels of 25 hydroxy D will be measured in mothers at 12, 16, 28 and delivery. Cord blood 25 hydroxy D and the infants' birthweight, length and head circumference will be measured at birth.

Eligibility criteria: Inclusion Criteria:

* Women who are within the ages of 18-45 years
* In good general health
* 12 weeks pregnant (based on last menstrual period)

Exclusion Criteria:

* Mothers with preexisting type I or type II diabetes
* Mothers with preexisting hypertension
* Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
* Mothers with multiple fetuses (e.g., twins, triplets, etc.)

Primary outcomes:
measure: Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
timeFrame: 12, 16, 28 weeks and at maternal delivery and neonatal birth
Secondary outcomes:
measure: Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth
timeFrame: At delivery
measure: Birthweight of Newborn Infant
timeFrame: Measured at birth.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Al-Ain
country: United Arab Emirates
facility: United Arab Emirated Unitersity
state: Abu Dhabi
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Adekunle Dawodu, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: United Arab Emirates University
name: Hussein F Saadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawodu A, Agarwal M, Sankarankutty M, Hardy D, Kochiyil J, Badrinath P. Higher prevalence of vitamin D deficiency in mothers of rachitic than nonrachitic children. J Pediatr. 2005 Jul;147(1):109-11. doi: 10.1016/j.jpeds.2005.03.001.
citation: Dawodu A, Agarwal M, Hossain M, Kochiyil J, Zayed R. Hypovitaminosis D and vitamin D deficiency in exclusively breast-feeding infants and their mothers in summer: a justification for vitamin D supplementation of breast-feeding infants. J Pediatr. 2003 Feb;142(2):169-73. doi: 10.1067/mpd.2003.63.
citation: Saadi HF, Dawodu A, Afandi BO, Zayed R, Benedict S, Nagelkerke N. Efficacy of daily and monthly high-dose calciferol in vitamin D-deficient nulliparous and lactating women. Am J Clin Nutr. 2007 Jun;85(6):1565-71. doi: 10.1093/ajcn/85.6.1565.
citation: Dawodu A, Wagner CL. Mother-child vitamin D deficiency: an international perspective. Arch Dis Child. 2007 Sep;92(9):737-40. doi: 10.1136/adc.2007.122689.
citation: Wagner CL, Taylor SN, Dawodu A, Johnson DD, Hollis BW. Vitamin D and its role during pregnancy in attaining optimal health of mother and fetus. Nutrients. 2012 Mar;4(3):208-30. doi: 10.3390/nu4030208. Epub 2012 Mar 21.
citation: Dawodu A, Tsang RC. Maternal vitamin D status: effect on milk vitamin D content and vitamin D status of breastfeeding infants. Adv Nutr. 2012 May 1;3(3):353-61. doi: 10.3945/an.111.000950.
citation: Dawodu A, Wagner CL. Prevention of vitamin D deficiency in mothers and infants worldwide - a paradigm shift. Paediatr Int Child Health. 2012 Feb;32(1):3-13. doi: 10.1179/1465328111Y.0000000024.
citation: Dawodu A, Saadi HF, Bekdache G, Javed Y, Altaye M, Hollis BW. Randomized controlled trial (RCT) of vitamin D supplementation in pregnancy in a population with endemic vitamin D deficiency. J Clin Endocrinol Metab. 2013 Jun;98(6):2337-46. doi: 10.1210/jc.2013-1154. Epub 2013 Apr 4.