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Maternal Vit D Supplements & Infant and Maternal Biomarkers & Outcomes in Southern Ethiopia

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ClinicalTrials.gov Identifier: NCT02210884
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Oklahoma State University

Brief Summary:
Synthesis of vitamin D in the skin through the action of sunlight is a major source of vitamin D in parts of the world where foods are not fortified with the vitamin. Skin pigmentation (color), dress habits and season are some of the factors that limit sun exposure and affect vitamin D synthesis in the skin. Maternal vitamin D status is especially important to meet infant needs when newborns are not supplemented with vitamin D. In Ethiopia, vitamin D status of lactating women and infants and breast milk vitamin D concentration have never been assessed. The purpose of this study is to assess changes in maternal and infant markers of vitamin D status before and after vitamin D supplementation of the lactating mothers.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Vitamin D Not Applicable

Detailed Description:
Vitamin D is a vitamin that regulates calcium and phosphorous homeostasis and ensures proper mineralization of bone. Lactating women and infants are considered to be at risk of vitamin D deficiency due to increased needs for vitamin D and calcium. Stores of vitamin D acquired in utero and breast milk are the main sources of vitamin D for infants. Maternal vitamin D deficiency, exclusive breastfeeding, skin pigmentation and limited sun exposure are commonly seen in infants with rickets. However, the UV exposure, dress habits, traditional practices and other risk factors to vitamin D deficiency in Ethiopia have not been explored. This study aims to fill this research gap.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Maternal Vitamin D Supplementation on Markers of Vitamin D Status and Related Infant and Maternal Outcomes in Southern Ethiopia
Study Start Date : October 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D
Weekly oral dose of 15,000 IU of Vitamin D3
Dietary Supplement: Vitamin D
Weekly oral supplementation with 15,000 IU vitamin D
Other Name: Vitamin D3

Placebo Comparator: Placebo
Placebo capsule containing no vitamin D
Dietary Supplement: Vitamin D
Weekly oral supplementation with 15,000 IU vitamin D
Other Name: Vitamin D3




Primary Outcome Measures :
  1. Plasma 25(OH)D concentrations of lactating women [ Time Frame: 3 months after enrollment ]
    Maternal plasma 25(OH) will be assessed at baseline and after three months of weekly supplementation with 15,000 IU vitamin D or placebo.

  2. Plasma 25(OH)D concentrations of lactating women [ Time Frame: 6 months after enrollment ]
    Maternal plasma 25(OH)D concentrations will be measured at 6 months after weekly supplementation with 15,000 IU vitamin D3 or placebo

  3. Plasma 25(OH)D concentrations of lactating women [ Time Frame: 1 year ]
    Maternal 25 (OH)D concentrations will be measured at 1 year after weekly supplementation with 15,000 IU of vitamin D or placebo

  4. Plasma 25(OH) vitamin D of infants at 6 months of age [ Time Frame: 6 months ]
    Plasma 25(OH) vitamin D of 6-month-old infants whose mothers received weekly doses of 15,000 IU vitamin D or placebo from time of enrollment

  5. Plasma 25(OH) vitamin D of 1-year-old infants [ Time Frame: 1 year ]
    Plasma 25(OH) vitamin D of 1-year-old infants whose mothers received weekly doses of 15,000 IU vitamin D or placebo from time of enrollment

  6. Breast milk concentration of vitamin D [ Time Frame: 3 months ]
    Breast milk concentration of vitamin D will be measured three months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo.

  7. Breast milk concentration of vitamin D [ Time Frame: 6 months ]
    Breast milk concentration of vitamin D will be measured six months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo.

  8. Breast milk concentration of vitamin D [ Time Frame: 1 year ]
    Breast milk concentration of vitamin D will be measured twelve months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo.

  9. Clinical Assessment of Infants for Rickets [ Time Frame: 3 months ]
    Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets

  10. Clinical Assessment of Infants for Rickets [ Time Frame: 6 months ]
    Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets

  11. Clinical Assessment of Infants for Rickets [ Time Frame: 12 months ]
    Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets


Secondary Outcome Measures :
  1. Infant motor developmental milestones [ Time Frame: Weekly for one year ]
    Progress toward standardized infant motor developmental milestones will be assessed weekly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment

  2. Infant acute respirtory tract infections [ Time Frame: Weekly for one year ]
    Incidence of infant acute respiratory tract infections will be assessed weekly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment

  3. Infant anthropometry [ Time Frame: Quarterly for one year ]
    Weight and length of infants will be assessed quarterly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210884


Locations
Ethiopia
Hawassa University
Hawassa, Ethiopia
Sponsors and Collaborators
Oklahoma State University
Investigators
Study Director: Barbara J Stoecker, PhD Oklahoma State University

Responsible Party: Oklahoma State University
ClinicalTrials.gov Identifier: NCT02210884     History of Changes
Other Study ID Numbers: HE1357
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017

Keywords provided by Oklahoma State University:
Vitamin D supplementation
Lactation
25 hydroxyvitamin D
Breast feeding

Additional relevant MeSH terms:
Vitamin D Deficiency
Vitamins
Vitamin D
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents