Status:
UNKNOWN
Vitamin B12, Neurodevelopment and Growth in Nepal
Lead Sponsor:
Centre For International Health
Collaborating Sponsors:
Tribhuvan University, Nepal
NORCE Norwegian Research Centre AS
Conditions:
Development
Vitamin Deficiency
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
PHASE3
Brief Summary
Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of Vitamin B12 is animal-source foods. Vitamin B12 is crucial for normal cell...
Detailed Description
Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of vitamin B12 is animal-source foods. Vitamin B12 is crucial for norm...
Eligibility Criteria
Inclusion
- Age 6 to 11 months
- Stunted
- Availability of informed verbal consent
- Plan to reside in the area for the next 12 months
Exclusion
- Severe systemic illness requiring hospitalization
- Severe malnutrition, i.e. weight for height \< -3 z of the WHO standard for this age group. For ethical reasons these children require micronutrient supplementation and adequate medical care.
- Lack of consent
- Taking B vitamin supplements that include vitamin B12.
- Severe anemia (Hb \< 7 g/dL). This would be a temporary exclusion and the children will be enrolled if they are successfully treated.
- Ongoing acute infection with fever or infection that requires medical treatment. This would be a temporary exclusion and the children will be enrolled after recovery.
Key Trial Info
Start Date :
April 20 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2024
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT02272842
Start Date
April 20 2015
End Date
December 28 2024
Last Update
September 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan
Bhaktapur, Nepal, P.O.Box 40