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A clinical trial to evaluate the need for routine Vitamin D supplementation till six months age in full term babies who are being exclusively breastfed.

Vitamin D Oral Supplementation Evaluation in full-term, exclusively breastfed infants -A randomized controlled study - VDOSE study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/08/006132
Enrollment
300
Registered
2015-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Full term infants

Interventions

Intervention1: Vitamin D: 400 IU daily orally from birth till six months of age Control Intervention1: No treatment: No treatment

Sponsors

Director Institute of Naval Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Born at 37 weeks completed gestation or thereafter; 2. Birth weight equal to or more than 2500 gm; 3. Exclusively breastfed; 4. Parents provide written consent for their infant to participate in the study after detailed information is disseminated to them

Exclusion criteria

Exclusion criteria: 1. Infants born before 37 completed weeks of gestation; 2. Low birth weight, i.e. birth weight less than 2500 gm; 3. Sick neonate, including birth asphyxia; 4. Neonate not exclusively breastfed from birth due to any reason even though may afterwards be on exclusive breastfeeds; 5. Neonates with major congenital anomalies, and, 6. Neonates whose parents decline consent to participate in the study. (Presence of any one criterion will result in exclusion)

Design outcomes

Primary

MeasureTime frame
Vitamin D levels in blood of study subjects as estimated by estimation of serum 25 hydroxy vitamin D (25OHD) level measured by radioimmunoassay using commercially available kitsTimepoint: 1. Levels in Umbilical Cord Blood at birth 2. Levels at 1 month age 3. Levels at 6 months age

Secondary

MeasureTime frame
1. Weight nearest to 10 gm, measured on a calibrated electronic weighing machine 2. Length nearest to 0.5 cm measured on an infantometer 3. Head circumference measured by a non-expansile tape measure to the nearest 0.5 cmTimepoint: 1. At Birth 2. At 1 month 3. At 6 months

Countries

India

Contacts

Public ContactDr Shankar Narayan

INHS Asvini

drshankarnarayan@gmail.com09869444479

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026