Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy- a Dose Comparison Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT02215213
• Date of registration: 06/08/2014
• Prospective Registration: No
• Primary sponsor: Aga Khan University
• Public title: Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy- a Dose Comparison Trial
• Scientific title: Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy
• Date of first enrolment: June 2013
• Target sample size: 350
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02215213
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Pakistan

Contacts

• Name: Sidrah Nausheen, FCPS
• Affiliation: Aga Khan University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pregnant women aged 15 - 45 years

- Less than 16 weeks pregnant from Last menstrual period.

- Agree to take part in this study, will be enrolled.

Exclusion Criteria:

- Pregnant women with pre existing type 1 or type II diabetes,

- Pregnant women with pre existing hypertension

- Women with multiple fetuses, babies (twins, triplets)

- Women with fetal anomaly in scan

- Refuse to participate in the study



Age minimum: 15 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy

Intervention(s)

Drug: Vitamin D supplement

Primary Outcome(s)

pregnancy out come [Time Frame: At delivery of neonate]

Secondary Outcome(s)

Prevalence of vitamin D deficiency in pregnant women [Time Frame: at recruitment into study (first trimester)]

Secondary ID(s)

PF8/0911

Source(s) of Monetary Support

Please refer to primary and secondary sponsors