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Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants

NCT ID: NCT00610688

Last Updated: 2021-10-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Prenatal Vitamin D3

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D

Group Type PLACEBO_COMPARATOR

Prenatal Vitamin

Intervention Type DRUG

Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery

2

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)

Group Type EXPERIMENTAL

Prenatal Vitamin

Intervention Type DRUG

Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery

Cholecalciferol (Vitamin D3)

Intervention Type DRUG

Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery

3

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).

Group Type EXPERIMENTAL

Prenatal Vitamin

Intervention Type DRUG

Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery

Cholecalciferol (Vitamin D3)

Intervention Type DRUG

Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery

Interventions

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Prenatal Vitamin

Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery

Intervention Type DRUG

Cholecalciferol (Vitamin D3)

Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery

Intervention Type DRUG

Cholecalciferol (Vitamin D3)

Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery

Intervention Type DRUG

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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United Arab Emirates University

OTHER

Sponsor Role collaborator

Thrasher Research Fund

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adekunle Dawodu, MBBS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Hussein F Saadi, MD

Role: PRINCIPAL_INVESTIGATOR

United Arab Emirates University

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

United Arab Emirated Unitersity

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Site Status

Countries

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United States United Arab Emirates

References

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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.

Reference Type BACKGROUND
PMID: 16027707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12584539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17556694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17715433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22666547 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22585912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22525442 (View on PubMed)

Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

Reference Type DERIVED
PMID: 39077939 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23559082 (View on PubMed)

Other Identifiers

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2008-0931

Identifier Type: -

Identifier Source: org_study_id