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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02210884
Date of registration:	06/08/2014
Prospective Registration:	Yes
Primary sponsor:	Oklahoma State University
Public title:	Maternal Vit D Supplements & Infant and Maternal Biomarkers & Outcomes in Southern Ethiopia
Scientific title:	Effects of Maternal Vitamin D Supplementation on Markers of Vitamin D Status and Related Infant and Maternal Outcomes in Southern Ethiopia
Date of first enrolment:	October 2014
Target sample size:	240
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02210884
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Ethiopia

Contacts

Name:	Barbara J Stoecker, PhD
Address:
Telephone:
Email:
Affiliation:	Oklahoma State University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Breastfeeding

- Available for enrollment within 2 weeks of delivery

- Residing in the study area in Ethiopia

- Apparently healthy

Exclusion Criteria:

- Self-reported chronic or acute disease condition

- Not breastfeeding

- Twin births

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Vitamin D Deficiency

Intervention(s)

Dietary Supplement: Vitamin D

Primary Outcome(s)

Breast milk concentration of vitamin D [Time Frame: 3 months]

Plasma 25(OH) vitamin D of infants at 6 months of age [Time Frame: 6 months]

Breast milk concentration of vitamin D [Time Frame: 6 months]

Plasma 25(OH)D concentrations of lactating women [Time Frame: 6 months after enrollment]

Clinical Assessment of Infants for Rickets [Time Frame: 3 months]

Plasma 25(OH)D concentrations of lactating women [Time Frame: 1 year]

Clinical Assessment of Infants for Rickets [Time Frame: 12 months]

Clinical Assessment of Infants for Rickets [Time Frame: 6 months]

Plasma 25(OH)D concentrations of lactating women [Time Frame: 3 months after enrollment]

Plasma 25(OH) vitamin D of 1-year-old infants [Time Frame: 1 year]

Breast milk concentration of vitamin D [Time Frame: 1 year]

Secondary Outcome(s)

Infant anthropometry [Time Frame: Quarterly for one year]

Infant acute respirtory tract infections [Time Frame: Weekly for one year]

Infant motor developmental milestones [Time Frame: Weekly for one year]

Secondary ID(s)

HE1357

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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