Vitamin D DeficiencyNCT02210884
Maternal Vit D Supplements & Infant and Maternal Biomarkers & Outcomes in Southern Ethiopia
A study testing Vitamin D in people with Vitamin D Deficiency, run by Oklahoma State University at 1 site in Ethiopia.
Trial 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. 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?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteEthiopia
- Study dates
- Oct 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Breastfeeding
- Available for enrollment within 2 weeks of delivery
- Residing in the study area in Ethiopia
- Apparently healthy
Who cannot join
- Self-reported chronic or acute disease condition
- Not breastfeeding
- Twin births
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Maternal Vitamin D Supplementation on Markers of Vitamin D Status and Related Infant and Maternal Outcomes in Southern Ethiopia
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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D
- Keywords
- Vitamin D supplementation, Lactation, 25 hydroxyvitamin D, Breast feeding
- Medical subject headings
- Vitamin D Deficiency, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called Vitamin D3
Weekly oral supplementation with 15,000 IU vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Weekly oral dose of 15,000 IU of Vitamin D3 Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Placebo capsule containing no vitamin D Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma 25(OH)D concentrations of lactating women
Maternal plasma 25(OH) will be assessed at baseline and after three months of weekly supplementation with 15,000 IU vitamin D or placebo.
Measured: 3 months after enrollment
Plasma 25(OH)D concentrations of lactating women
Maternal plasma 25(OH)D concentrations will be measured at 6 months after weekly supplementation with 15,000 IU vitamin D3 or placebo
Measured: 6 months after enrollment
Plasma 25(OH)D concentrations of lactating women
Maternal 25 (OH)D concentrations will be measured at 1 year after weekly supplementation with 15,000 IU of vitamin D or placebo
Measured: 1 year
Plasma 25(OH) vitamin D of infants at 6 months of age
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
Measured: 6 months
Plasma 25(OH) vitamin D of 1-year-old infants
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
Measured: 1 year
Breast milk concentration of vitamin D
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.
Measured: 3 months
Breast milk concentration of vitamin D
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.
Measured: 6 months
Breast milk concentration of vitamin D
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.
Measured: 1 year
Clinical Assessment of Infants for Rickets
Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets
Measured: 3 months
Clinical Assessment of Infants for Rickets
Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets
Measured: 6 months
Clinical Assessment of Infants for Rickets
Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets
Measured: 12 months
Secondary outcomes (3)
Infant motor developmental milestones
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
Measured: Weekly for one year
Infant acute respirtory tract infections
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
Measured: Weekly for one year
Infant anthropometry
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
Measured: Quarterly for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara J Stoecker, PhD, Study director, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210884
- Sponsor's protocol ID
- HE1357
- Status last verified
- Feb 2017
- First submitted
- 6 Aug 2014
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Girma M, Argaw A, Tilahun Tadesse B, Mulugeta B, Chowanadisai W, Stoecker BJ. Effects of weekly cholecalciferol supplementation of lactating mothers on vitamin D status, and infant growth and gross motor development: a randomized controlled trial in rural Ethiopia. Am J Clin Nutr. 2025 Nov;122(5):1306-1316. doi: 10.1016/j.ajcnut.2025.07.028. Epub 2025 Aug 5.
PubMed 40754215
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Maternal Vitamin D Supplementation on Markers of Vitamin D Status and Related Infant and Maternal Outcomes in Southern Ethiopia
- ClinicalTrials.gov ID
- NCT02210884
- Acronym / sponsor ID
- HE1357
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D supplementation, Lactation, 25 hydroxyvitamin D, Breast feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: Vitamin DWeekly oral dose of 15,000 IU of Vitamin D3 |
| Placebo | Placebo comparator | Dietary Supplement: Vitamin DPlacebo capsule containing no vitamin D |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Breastfeeding
- Available for enrollment within 2 weeks of delivery
- Residing in the study area in Ethiopia
- Apparently healthy
Key exclusion criteria (3 listed)
- Self-reported chronic or acute disease condition
- Not breastfeeding
- Twin births
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 |
|---|---|---|
| Vitamin DAlso: Vitamin D3Weekly oral supplementation with 15,000 IU vitamin D | Dietary supplement | Placebo, Vitamin D |
Primary outcome
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.
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
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
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
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
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.
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.
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.
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
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
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
3 secondary outcomes
Infant motor developmental milestones
Time frame: Weekly for one year
Infant acute respirtory tract infections
Time frame: Weekly for one year
Infant anthropometry
Time frame: Quarterly for one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Derived from this study: PubMed 40754215Girma M, Argaw A, Tilahun Tadesse B, Mulugeta B, Chowanadisai W, Stoecker BJ. Effects of weekly cholecalciferol supplementation of lactating mothers on vitamin D status, and infant growth and gross motor development: a randomized controlled trial in rural Ethiopia. Am J Clin Nutr. 2025 Nov;122(5):1306-1316. doi: 10.1016/j.ajcnut.2025.07.028. Epub 2025 Aug 5.
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.
Barbara J Stoecker, PhD study director
Oklahoma State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Deficiency, run by Oklahoma State University at 1 site in Ethiopia.
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 4 inclusion and 3 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 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma 25(OH)D concentrations of lactating women (time frame: 3 months after enrollment). The study lists 11 primary outcomes in all. 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 NCT02210884, which also lists 1 linked publication.
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 6 Feb 2017.