Vitamin D DeficiencyPhase 3PA 03-103NCT00610688

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

A Phase 3 study testing Prenatal Vitamin and Cholecalciferol (Vitamin D3) in people with Vitamin D Deficiency, run by Children's Hospital Medical Center, Cincinnati at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Vitamin D Deficiency
What is being tested?: Prenatal Vitamin and Cholecalciferol (Vitamin D3)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 192 participants
Where: 2 sitesin 2 countries
Study dates: Jan 2008to Apr 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.)

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

United Arab Emirates1 site

United Arab Emirated Unitersity
Al Ain City, Abu Dhabi Emirate

Other trials in United Arab Emirates

About this study

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

Read the 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.

Conditions: Vitamin D Deficiency
Being tested: Prenatal Vitamin, Cholecalciferol (Vitamin D3)
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.

Prenatal VitaminDrug
Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
Cholecalciferol (Vitamin D3)Drug
Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
Cholecalciferol (Vitamin D3)Drug
Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery

Study groups in NCT00610688
Study group	Role	What they receive
Prenatal Vitamin D3	Placebo comparator	Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D Receives: Drug: Prenatal Vitamin
2	Experimental	Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3) Receives: Drug: Prenatal Vitamin; Drug: Cholecalciferol (Vitamin D3)
3	Experimental	Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3). Receives: Drug: Prenatal Vitamin; Drug: Cholecalciferol (Vitamin D3)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement
Measured: 12, 16, 28 weeks and at maternal delivery and neonatal birth

Secondary outcomes (2)

Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth
Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth
Measured: At delivery
Birthweight of Newborn Infant
Growth of the Newborn Infant as Measured by Birthweight in grams.
Measured: Measured at birth.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Apr 2012

First posted8 Feb 2008 (estimated)
Study startJan 2008
Primary completionJun 2011
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)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 Children's Hospital Medical Center, CincinnatiThe 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00610688
Sponsor's protocol ID: 2008-0931
Acronym: PA 03-103
Status last verified: Sep 2021
First submitted: 27 Dec 2007
Last updated: 19 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 16027707
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.
PubMed 12584539
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.
PubMed 17556694
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.
PubMed 17715433
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.
PubMed 22666547
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.
PubMed 22585912
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.
PubMed 22525442
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.
PubMed 39077939
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.
PubMed 23559082

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia

All Vitamin D Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00610688
Acronym / sponsor ID: PA 03-103 / 2008-0931
Conditions: Vitamin D Deficiency
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Collaborators: United Arab Emirates University, Thrasher Research Fund
Study start: Jan 2008
Primary completion: Jun 2011 (actual)
Study completion: Apr 2012 (actual)
First posted: 8 Feb 2008 (estimated)
Results: Posted 7 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
Prenatal Vitamin D3	Placebo comparator	Drug: Prenatal VitaminArm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D
2	Experimental	Drug: Prenatal Vitamin, Drug: Cholecalciferol (Vitamin D3)Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)
3	Experimental	Drug: Prenatal Vitamin, Drug: Cholecalciferol (Vitamin D3)Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.)

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
Prenatal VitaminOnce daily, prenatal vitamin containing 400IU of Vitamin D, until delivery	Drug	2, 3, Prenatal Vitamin D3
Cholecalciferol (Vitamin D3)Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery	Drug	2
Cholecalciferol (Vitamin D3)Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery	Drug	3

Primary outcome

Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
Time frame: 12, 16, 28 weeks and at maternal delivery and neonatal birth
Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement

2 secondary outcomes

Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth
Time frame: At delivery
Birthweight of Newborn Infant
Time frame: Measured at birth.

Results and safety

Results posted to the registry on 7 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
400 IU	64	55
2000 IU	65	52
4000 IU	63	55

Primary outcome: Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement

Time frame: 12, 16, 28 weeks and at maternal delivery and neonatal birth. Mean (Standard Error). Unit: nmol/L

Measure	400 IU n = 55	2000 IU n = 52	4000 IU n = 55
Maternal at 12 Weeks	21.5 (1.6)	20.5 (1.5)	19.6 (1.0)
Maternal at 16 Weeks	40.7 (2.1)	53.7 (2.3)	60.7 (3.3)
Maternal at 28 Weeks	53.9 (3.2)	82.3 (4.4)	88.2 (4.2)
Maternal at Delivery	48.2 (3.1)	64.9 (4.0)	89.8 (4.6)
Neonatal at Birth	36.9 (2.8)	48.3 (3.5)	66.1 (3.2)

Population analysed: Intention to treat analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
400 IU	0 of 64 (0%)	0 of 64 (0%)	Not reported
2000 IU	0 of 65 (0%)	0 of 65 (0%)	Not reported
4000 IU	0 of 63 (0%)	0 of 63 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16027707Dawodu 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.
Background: PubMed 12584539Dawodu 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.
Background: PubMed 17556694Saadi 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.
Background: PubMed 17715433Dawodu 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.
Background: PubMed 22666547Wagner 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.
Background: PubMed 22585912Dawodu 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.
Background: PubMed 22525442Dawodu 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.
Derived from this study: PubMed 39077939Palacios 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.
Derived from this study: PubMed 23559082Dawodu 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.

Related trials for Vitamin D Deficiency

RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia

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.

Adekunle Dawodu, MBBS principal investigator

Children's Hospital Medical Center, Cincinnati

Hussein F Saadi, MD principal investigator

United Arab Emirates University

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prenatal Vitamin and Cholecalciferol (Vitamin D3) in people with Vitamin D Deficiency, run by Children's Hospital Medical Center, Cincinnati at 2 sites in 2 countries.

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 3 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 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, United Arab Emirates. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement (time frame: 12, 16, 28 weeks and at maternal delivery and neonatal birth). 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 NCT00610688, which also lists 9 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 19 Oct 2021.