The Effect Of Pumpkin Seed Extract Capsules On Nutritional Status and Haemoglobin Level in Pregnant Women.

NCT05657821 | Unknown Early Phase 1

• 1 other identifier: Indonesia TimurU
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this to measure the effect of supplementation of Yellow Pumpkin Seed Extract Capsules in pregnant women on hemoglobin levels and nutritional status of pregnant women. The main question\[s\] it aims to answer are:

• is there a difference in changes in nutritional status (increase in body weight and MUAC) in pregnant women who receive supplementation of Pumpkin Seed Extract Capsules and iron tablets
• is there a difference in changes in hemoglobin levels in pregnant women who receive supplementation of Pumpkin Seed Extract Capsules and iron tablets. The research sample was divided into two groups, namely the intervention group and the control group. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks, while the control group received iron tablets for 12 weeks as well. Measurements of nutritional status (including measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out. As for measuring blood hemoglobin levels, it was taken before the intervention and after the intervention for 12 weeks

Conditions

Anemia During Pregnancy

Outcome Measures

Primary Outcomes (2)

• Nutritional status

  measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out

  12 weeks

• hemoglobin levels

  Hemoglobin level in the blood is measured by taking blood from the fingertip. Then measured using the digital strip method.

  12 weeks

Study Arms (2)

pumpkin seed extract capsules

EXPERIMENTAL

. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks

Dietary Supplement: Pumpkin seeds extract capsules

Iron tablets

PLACEBO COMPARATOR

the control group received iron tablets for 12 weeks

Dietary Supplement: Pumpkin seeds extract capsules

Interventions

Pumpkin seeds extract capsules DIETARY_SUPPLEMENT

the intervention group was given pumpkin seed capsules for 12 weeks, and the intervention group was given iron tablets for 12 weeks

Iron tablets; pumpkin seed extract capsules

Eligibility Criteria

• Age: 17 Years - 39 Years
• Gender Eligibility Details: pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• in the one or second trimester of pregnancy;
• having no complications;
• willing to participate in this study;
• domiciled in the stunting locus village Bone regency .

You may not qualify if:

• Pregnant women with complications

Sponsors & Collaborators

• Dr. Rosdiana Syakur: lead
• Hasanuddin University: collaborator

Study Sites (1)

Stunting Locus Village

Bone, South Sulawesi, 90000, Indonesia

RECRUITING

Central Study Contacts

Rosdiana Syakur

CONTACT

+6285299856839; rosdianaary@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Indonesia Timur University

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: December 20, 2022
• Study Start: October 25, 2022
• Primary Completion: January 25, 2023
• Study Completion: August 25, 2023
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: when the study is done

Locations

ID (1)