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A study of the effect of vitamin D supplementation in pregnant women, on the growth and biochemical features of the newborn baby and infant.

Vitamin D and calcium nutrition: deficiency and evaluation of supplementation.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000499
Enrollment
300
Registered
2010-05-19
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

None listed

Interventions

Intervention1: Oral vitamin D3: Group 1 receives one sachet of 60,000 units of D3 by mouth, in mid trimester
group 2 receives 2 sachets in mid trimester and 2 sachets in 7th month of pregnancy. Both groups receive 1 gm elemental calcium as calcium carbonate, daily orally. Control Intervention1: Oral calcium:

Sponsors

Department of endocrinology, SGPGIMS, Lucknow
Lead Sponsor
Department of obstetrics and gynecology, Queen Mary&#039
Collaborator
s Hospital, Chatrapati Sahuji Maharaj Medical University, Lucknow.
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All pregnant women who attend antenatal clinic of one unit of Queen Mary Hospital, Chhatrapati Sahuji Maharaj Medical University, Lucknow, are recruited as subjects and randomised to receive one of the 2 intervention regimes. Consecutive women who attend antenatal clinic too near term to be included in the study to serve as controls.

Exclusion criteria

Exclusion criteria: Patients already on calcium or on vitamin D supplementation, on anticonvulsants, on antitubercular treatment or having any medical condition affecting calcium and vitamin D metabolism (e.g. renal or liver disease).

Design outcomes

Primary

MeasureTime frame
Neonatal serum calciumTimepoint: At 4 to 6 day of life

Secondary

MeasureTime frame
Baby weight, length, head circumference, anterior fontanelle diameterTimepoint: 3 month of age;Baby weight, length, head circumference, anterior fontanelle diameterTimepoint: Birth;Baby weight, length, head circumference, anterior fontanelle diameterTimepoint: Nine month of age;Baby weight, length, head circumference, anterior fontanelle diameterTimepoint: Six month of age;Cord blood 25 OHD3Timepoint: Birth;Cord blood alkaline phosphataseTimepoint: Birth

Countries

India

Contacts

Public ContactVijayalakshmi Bhatia
vbhatia@sgpgi.ac.in+91-522-2494380

Outcome results

None listed

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